Medical Device Manufacturer · US , Cambridge , MA

Genzyme Corp. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1991

Official Website

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genzyme Corp. Microbiology ✕

3 devices

1-3 of 3

Cleared Jun 12, 2006

OSOM INFLUENZA A&B TEST

Microbiology · 11d

Cleared Feb 21, 2006

GENZYME OSOM INFLUENZA A & B TEST

Microbiology · 281d

Cleared Apr 02, 2004

GENZYME OSOM TRICHOMONAS RAPID TEST

Microbiology · 112d