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$ARYC Microarray product line has been submitted to

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Penny Traders Club Member Level  Monday, 01/07/19 11:16:53 PM
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$ARYC Microarray product line has been submitted to the FDA & now pending approval.


1-2-18: Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance https://www.fda.gov


Allergenex/Spiriplex:

Microarray finger stick allergy testing clinical trials...

https://clinicaltrials.gov/ct2/show/NCT03514303

Start date of clinical trials was May2018.

Completion date of clinical trials is February 2019.

Sponsor United Allergy Services located in San Antonio Texas.

https://www.unitedallergyservices.com/united-allergy-services-about/

https://allergyfreesolutions.com/item/microarraytechnology/

http://spiriplex.com/allergies/


Arrayit business development team reports revenues and earnings expansion opportunity with a leading allergy testing clinic headquartered in San Antonio Texas USA and serving the massive health and wellness allergy and asthma testing services markets (link: http://arrayit.com/Clinical/clinical.html) arrayit.com/Clinical/clini…

https://mobile.twitter.com/arrayit/status/1080873628382638080



Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration

https://www.yahoo.com/amphtml/finance/news/arrayit-corporation-ships-clinical-instrumentation-093000351.html


https://www.fpds.gov/ezsearch/fpdsportal?q=arrayit&s=FPDSNG.COM&templateN=&&templateName=1.5.1&indexName=awardfull



Market’s first high-performance blood card technology... Blood card technology is pending 510(k) submission and is not to be used for in vitro diagnostics prior to FDA approval.

http://www.arrayit.com/Microarray_Diagnostics/Blood_Cards/blood_cards.html



510(k) Clearance to Market:

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

http://www.qrasupport.com/FDA_MED_DEVICE.html


See the similarities :)

http://spiriplex.com/science/

smile
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