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. Chemistry ✕

17 devices

1-12 of 17

Cleared Jun 25, 2004

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

Chemistry · 143d

Cleared Jan 16, 2003

GENZYME CONTRAST II HCG URINE/SERUM TEST

Chemistry · 86d

Cleared Jul 25, 2002

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2

Chemistry · 91d

Cleared Aug 10, 2001

GENZYME DIRECT-AMYLASE TEST REAGENT

Chemistry · 59d

Cleared Oct 18, 1999

N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL...

Chemistry · 62d

Cleared Oct 04, 1999

GENZYME DIRECT AMYLASE VERIFIER

Chemistry · 14d

Cleared Nov 25, 1998

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

Chemistry · 34d

Cleared Jun 18, 1997

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR,...

Chemistry · 49d

Cleared Jun 16, 1997

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR

Chemistry · 77d

Cleared Jun 16, 1997

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

Chemistry · 77d

Cleared Aug 19, 1996

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

Chemistry · 74d

Cleared Mar 15, 1995

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

Chemistry · 258d