Medical Device Manufacturer · CA , Ottawa Ontario

DNA Genotek, Inc. - FDA 510(k) Cleared Devices

7 submissions · 6 cleared · Since 2011

7

Total

6

Cleared

1

Denied

FDA 510(k) Regulatory Record - DNA Genotek, Inc. Microbiology ✕

1 devices

1-1 of 1

Not Cleared Nov 03, 2021

OMNIgene GUT Dx

DEN200040 · QPO

Microbiology · 506d