Replies to post #86734 on Decision Diagnostics Corp (DECN)

[IPwatcher]

So it looks like GenAccord may simple be a reboxing of an HMD Biomedical Inc. product line?

Looks like HMD had an FDA warning letter in 2017.
They got a 510K approval in 2019 so I would assume that they probably got out from under this OK however.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hmd-biomedical-inc-499698-08312016

You can see all their device listings by typing HMD biomedical into the applicant name box on this search from from the FDA website.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

K121433 or K113314 seem closest in intended use to DECNs Genaccord published information from what I can see. But there is a degree of speculation in there.

It seems unlikely that the FDA cleared 'GenAccord' was developed by DECN themselves though. Pharmatech website suggests it is a rebadged HMD Biomedical product