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Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH).
The owner of the device/product could have designed it, but then had it manufactured by a contract manufacturer.
Do You Know…
What It Means When FDA "Clears" or "Approves" a Medical Device?
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193731.htm
A trade mark and a FDA approval with Establishment number are in differing leagues......
Yep must be true we all read it on a message board ,,,,,
FDA Establishment FACTS are FALSE,,,,,,,,,
Hmmm Which one should i Believe ,,,,,, wait I am Thinking,,,,
No think I will Believe the FDA ......
The positive you missed however is look at the Clearance approvals for other PRIVATE LABEL names they can sell GEN-Strip with HMMMM........ but the FDA is FALSE,,,, it was not on a MESSAGE board....
I would not be so sure that Korea is the contract MFG.... or they are once again in VIOLATION and will get another PESKY Violation Letter.
discretion is not a Approved Device for PHARMA Tech,,,, if it were it would be listed along with there other APPROVED Devices...
Establishment Registration & Device Listing
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Registration Number Current
Registration Yr
PHARMA TECH SOLUTIONS, INC. CA/USA
3007197758 2015
PharmaTech Solutions, Inc PA/USA
3008282042 2015
glucose oxidase, glucose - Alltara!â„¢; Dynastripsâ„¢; GenStripâ„¢; GenStripâ„¢50; GenUltimateâ„¢; ValuChoiceâ„¢
Manufacturer
system, test, blood glucose, over the counter - Alltara!â„¢; Dynastripsâ„¢; GenStripâ„¢; GenStripâ„¢50; GenUltimateâ„¢; ValuChoiceâ„¢
Manufacturer
Establishment:
PharmaTech Solutions, Inc
950 borom rd
york , PA 17404
Registration Number: 3008282042
Status: Active
Date of Registration Status: 2015
Owner/Operator:
Pharma Tech Solutions, Inc.
2660 townsgate road
suite 300
westlake village, CA 91361
Owner/Operator Number: 10027212
Official Correspondent:
keith m berman
Genstrip
2660 townsgate road
suite 300
westlake village, CA 91361
Phone: 805-4462973
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=170279
They have legal right to sell it th ey have been issued a 510K... as far as private label all they need is a PMA.... and a customer....
Here's one reason
What does J+J gain from dragging this out?
JNJ/Lifescan sales in Diabetic care each year is around 480 million
so far litigation has kept DECN out of the market to capture what percentage of...those sales ........
they will fight to the end ........ even if it means stalling,,,,,
Sure ... I can be a paid witness for any one.. I will certainly say what I know.
But tomarrow I will go see if I can find dynastrip.....
Because at the end of the day if your not depositing cash in the bank ......
I dont think you won..
Soon, just around the corner... lets see the judge is putting it on his docket in what decade?..
Yep agreed..... just ran down to CVS to pick up a box ... well ..then I went to Rite aid.... well .... then I ran over to Walgreens, yep nope not there either. . So I stopped at Walmart .... yep you guessed it, none there........ so alass I gave up...
I beat JnJ THREE TIMES ... but at the end of the day, how many months / years since the last victory . I still can not find
them on the shelf of any major Pharmacy..or small Pharmacy...
So tell me WHO won ?....
It will be
DYNAmic as they STRIP jnj of all there cash…. Soon,,,, Real Soon …….LOL
JnJ has no reason to speed along any type of conclusion, they have taken residence with the slowskys.
When they acquired genstrip from Shasta they held up the filings then also, For Government Paperwork & Change of ownership, it was a FDA approved Class II item. did you see the contract in the last few filings on the Genstrip deal , see sometimes its what is not in the filing.
just sayin .......
I would only be assuming this property is not a FDA Class II item.
Dang Government or Lawyers or ????
OK ... Yep that nasty ole government,,,,, they just take my money and do nothing for it,
KOPPEL, PATRICK, HEYBL & PHILPOTT
have been long time associates of Mr.Berman for Patent advice and filings.
a small hint the patent office has the best electronic filing system of all the agency's...
No I assume Nothing, the Company Filed this statement.
In March 2015 we acquired patents which shall serve
our business interests now and into the future
OTC Markets
DECN — Management Discussion and Analysis
OTC PINK QUARTERLY REPORT FOR PERIOD ENDED 3/31/2015
http://www.otcmarkets.com/financialReportViewer?symbol=DECN&id=137327
Well as we both know Genstrip has no patent.
Pharma Tech Solutions, Inc has a Patent application only on file HEALTHCARE INFORMATION MANAGEMENT AND COMMUNICATIONS SYSTEM AND METHOD
Mr Berman & Ms Asbell from there CYMEDIX CORPORATION days have one also.
So there is no opinion just looking for fact !
I also Asked for a Link Showing the Statement.
I am only interested in FACT! not Fiction
Sure here is the link for a Patent Assignment search, as soon as you find the patents let us all know.
http://assignment.uspto.gov/#/
The 2 patents are all about leverage. DECN bought them from a small company that sued J&J for patent infringement. J&J stonewalled them in the courts, and they ran out of money to fight back. So the patents just sat inactive while apparently J&J made billions on them.
I missed the above statement in the filings ,,
Can you provide the correct link ? or is this just an opinion ...
Also can you supply a link to the patent assignment
that will clear it all ... we can read the patent link.
What Subsidiary were the patents assigned to?
No we all know about that case .. we are all waiting for a result...
What I am refering to is he specificly stated ... JnJ and the FDA were interfering with Phamatech in selling private label strips... re read all the post and the quote..
I certainly will as soon as you provide the Documents of your claim
ksviking12 has replied to a post you made on Decision Diagnostics Corp. on Investors Hub:
Hard when JnJ tampers with the FDA to block private labels.
Not funny .... you made a statement j&j tampered with the FDA.. on private label ... I asked for the proof of phama's filing for a private label .... and I will contact as a Shareholder why they are holding these aplications....
Have a contract with walmart how can it be that hard ? ... once again send me a link on the PMA / 510K private label aplications and I will contact The FDA to find out why they are holding the aplications. And I will copy the SG because he is already intervieeing on DECN's behalf...
R U. Saying phama has filed for pma's and 510k approvals and the FDA is holding them up. Please supply the application link. And why has phama not filed suit against the FDA? they have a pre approved and cleared product to sell ... its only paperwork on a sold under brand also .
Gota get them on the shelfs and educate the consumer and pharmacist. .. so far wonder man after a year has been unable to crack the market .... hmmm..
Not even all the tv commercials did it..
So the stock options awarded are not compensation? ... what are they then ...
If he choses not to exercise the options thats on him. Its still booked compensation. Per the filings.
Ps you dont think he could be getting a salary as a executive from one of the subsidiary companys ..the non reporting ones do you?...
A great example of someone putting blinders on and not looking at the real picture...if it were happening they would be reporting it...
Theres a legal plan and a bussiness plan.
They hired a well known industry exec.. and he has not been able to use his relationships to make a customer... or is he trying. .. sales are made on relationships and loyalty daily... hmmm
One year now isnt it..
Yep and Daivd beat Goliath.... but still no real business plan or sales..... company decides to delist....
Thats not a plan its a hail mary..
when its all said and done ya gotta have real sales that have real margins. With real customers..
Yep and Daivd beat Goliath.... but still no real business plan or sales..... company decides to delist....
Thats not a plan its a hail mary..
when its all said and done ya gotta have real sales that have real margins. With real customers..
Then again I am a long long term shareholder ... that is now completely dissatisfied with current decisions made by management.... and still holding a bag.
Now its a wing and a prayer approach.
Exactly ..
Ha! Speaking directly to the companies management is unverifiable?
there is NO WAY to verify a phone conversation ..... if the company wants you to know something they need to do the LEGAL thing and Disclose it ,!!
Not with a phone conversation to a shareholder or potential investor to spread rumor on a public message board ,,,,
but then again if made said it on the other board it must be alright,
if you change the color of the lipstick its still a PIG.
No there is no guessing.
I read it in there Filings. what little they disclose ,,,,
If the company was forth coming ,,,, they would disclose it!
you know use the LEGAL way to do it .. not in a UNVERIFIABLE phone conversation ...
My cousins sisters boyfreinds sister inlaws next door neighbor down the street from Sam told me also ,,,,,it was covered in a phone conversation with DECN.
Yep if they were doing that (alternative Route )WHY then did they not Hire
an Attorney from the DAD list ?
Designed for investor-focused companies that meet high financial standards, are current in their disclosure and receive third party advisory. The companies found on OTCQX are distinguished by the excellence of their operations and diligence with which they convey their qualifications.
OTCQX® best marketplace is for established, investor-focused U.S. and global companies. To qualify for the OTCQX marketplace, companies must meet high financial standards, demonstrate compliance with U.S. securities laws, be current in their disclosure, and be sponsored by a professional third-party advisor. Designed for investor-focused companies, OTCQX ensures that investors and brokers have the quality of information that’s necessary to intelligently analyze, value, and trade their securities.
Instead I think we are here
The OTC Pink® marketplace offers trading in a wide spectrum of equity securities through any broker. This marketplace is for all types of companies that are there by reasons of default, distress or design, which is why they are further segmented based on the level of information that they provide.
If you find that a company does not provide high quality information, be extra careful and cautious. Investors are strongly advised to thoroughly and carefully research companies before making any investment decisions.
Yep ....... think the lipstick has been applied...
BRAVO .....
if you dress up a pig & put lipstick on it .....
you still just have a PIG.
As a reminder to all DECN has always prepared there own Financials and the accounting firms only AUDITED what they were Shown ,
here are STATEMENTS Signed by thier Attorney or Mr. Berman for the LAST THREE YEARS OF FILING ,,
Not opinion ALL FACT!
From Attorney Letter with Respect to Current Information - OTC PINK ANNUAL REPORT 2013-2014 OPINION OF COUSEL Pg 2
http://www.otcmarkets.com/financialReportViewer?symbol=DECN&id=135856
Kieth Berman, Chief Financial Officer of the Issuer, is responsible for the preparation of the unaudited financial statements contained in the Report. The qualifications of Mr.Berman are outlined in his biographical information set forth in the report.
From : Attorney Letter with Respect to Current Information - Attorney Disclosure and Opinion for 2012-2013 Annual Report OTC Pink pg2
http://www.otcmarkets.com/financialReportViewer?symbol=DECN&id=135135
Kieth Berman, Chief Financial Officer of the Issuer, is responsible for the preparation of the unaudited financial statements contained in the Report. The qualifications of Mr.Berman are outlined in his biographical information set forth in the report.
From Dec 31 2012 10K Pg 23
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9225698
Management Responsibility for Financial Information
We are responsible for the preparation, integrity and fair presentation of our financial statements and the other information that appears in this annual report on Form 10-K. The financial statements have been prepared in accordance with accounting principles generally accepted in the United States and include estimates based on our best judgment.
We maintain a system of internal controls and procedures designed to provide reasonable assurance, with an appropriate cost-benefit relationship, that our financial information is accurate and reliable, our assets are safeguarded, and our transactions are executed in accordance with established procedures.
We retained L.L. Bradford & Company (2012) and Weaver Martin & Samyn LLC (2011) independent registered public accounting firms, to audit our consolidated financial statements. Their accompanying reports are based on audits conducted in accordance with the standards of the Public Company Accounting Oversight Board (United States).
Regardless at the Present time ... they are a NON FILING COMPANY... They filed the form ... to become non filing. ..... that could mean countless things . Any thong that you or I posy curently would be a opinion only ..... so don't miss lead and say its for uplisting...
Need sec filing reports per OTC to file and up list if you want to be a OTC QX. And cash ... fees ..... . If you want big boards then you MUST be a SEC filer...
C
A non curent sec filer is not good
It means they are no longer a sec filing company....and are not required to follow sec filing guides....... they only need to file mimimum reports under OTC GUIDES..
NOT so good for a common share holder.
Your correct if they were a 10K audited for the missing 2013 year.... lets not lose site the 2014 is missing ,well kinda he has till 6:00pm est ... but will need to 10k for 2013
And the missing Qs ..not just the 2013 lawyer opinion...posted.. to stay a trading security......
Why then if they don't want to report ,,,,,,,
they FILE a LEGAL SEC Document ? and he SIGNED IT,
and File a OTC Preliminary Financial ?
HMMMM Let me Guess...... I am Thinking ,,,,,
I got it ,,,,,I got It .......
TO SELL SHARES ..
So you are Saying Mr Berman Filed a legal SEC report and Signed it,
with no intention of being able to comply?
we will see by 6:00 PM EST tonight.
Actually
the Company Filled this NT10K Stating this ,,,,
so its DUE TODAY
(b) The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, Form 11-K, Form N-SAR or Form N-CSR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report or transition report or transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date; and
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10604213
Ok what eva........ bottom line is they are not audited fins ......... they are being done in house by some one on staff.... and being over seen by kb wink wink..... see his credentials and bio........ if a real accounting firm was handleing it .... they would balance and be up to date .......