Medical Device Manufacturer · US , Cambridge , MA

Genzyme Corporation - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2005

Recent clearances: OSOM C. DIFFICILE TOXIN A/B TEST, OSOM INFLUENZA A&B TEST , MODEL PN190, GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared May 15, 2008

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

Chemistry · 66d