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. Hematology ✕

3 devices

1-3 of 3

Cleared Mar 21, 2000

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

Hematology · 54d

Cleared Feb 05, 1996

PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)

Hematology · 138d

Cleared Jun 25, 1993

PREDICTA ERYTHROPOIETIN KIT

Hematology · 185d