Medical Device Manufacturer · CA , Quebec

Geneohm Sciences Canada, Inc. (Bd Diagnostics) - FDA 510(k) Cleared D...

4 submissions · 3 cleared · Since 2013

4

Total

3

Cleared

1

Denied

FDA 510(k) cleared devices by Geneohm Sciences Canada, Inc. (Bd... Microbiology ✕

4 devices

1-4 of 4

Cleared Oct 21, 2019

BD MAX Vaginal Panel

Microbiology · 90d

Not Cleared Oct 28, 2016

BD MAX Vaginal Panel, BD MAX Instrument

DEN160001 · PQA

Microbiology · 291d

Cleared Nov 26, 2013

BD MAX STAPHSR ASSAY, INSTRUMENT

Microbiology · 78d

Cleared Apr 02, 2013

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

Microbiology · 36d