Replies to post #86726 on Decision Diagnostics Corp (DECN)

[IPwatcher]

The mystery is Genaccord! RelyMX which is supposed to be FDA cleared according to the Pharmatech website. but whoever 'cleared' this was not DECN, Pharmatech, nor The Bio Co. The 510K submission number will be on the box, so we will see whose strips DECN are now rebadging and selling there, if/when this info becomes available.!

Further Update
On the pharmatech product website where the Genaccord RelyMX product image is displayed there is a rendered image which says 'Genaccord Diabetic test strips ... The To go pack'.

If you zoom in on the image at the bottom left corner where Pharmatech solutions Inc. are listed as the supplier, you can see that HMD Biomedical Inc, Taipai, Taiwan are listed as the manufacturer.
You have to magnify alot, but the text is there and it is clear enough.
So it looks like GenAccord may simple be a reboxing of an HMD Biomedical Inc. product line?

HMD have a number of Approved 510K submissions, including the following:

K072369
K113307
K120064
K121433
K131173
K140150
K182428

It is likely to be one or other of these 510Ks (and/or a similar strip based 510K) that DECN are or will be "rely"ing on to sell these test strips in the US.

And if so, pretty clear that DECN did not develop this themselves.
But that would explain why these products are listed as 'FDA cleared' despite no DECN/Pharmatech solutions/The Bio Co 510K.

Some of the strip renderings shown on Pharmatech solutions Inc. look similar to this:
https://www.hmdbio.com/product