Medical Device Manufacturer · US , Cambridge , MA

Genzyme Corporation - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2005

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genzyme Corporation Microbiology ✕

2 devices

1-2 of 2

Cleared Dec 21, 2010

OSOM C. DIFFICILE TOXIN A/B TEST

Microbiology · 134d

Cleared Sep 25, 2009

OSOM INFLUENZA A&B TEST , MODEL PN190

Microbiology · 29d