Medical Device Manufacturer · US , San Diegi , CA

Genzyme Diagnostics - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1996

Recent clearances: OSOM HCG COMBO TEST, GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY, GENZYME DIAGNOSTICS CONTRAST MONO

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Apr 12, 2005

OSOM HCG COMBO TEST

Chemistry · 124d

Cleared Nov 25, 1996

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

Chemistry · 40d

Cleared Nov 25, 1996

CONTRAST STRIP HCG

Chemistry · 40d