Genzyme Corp. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genzyme Corp. Chemistry ✕
17 devices
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
Cleared
Oct 28, 1993
GENZYME A-AMYLASE TEST REAGENT
Chemistry
108d
Cleared
Jan 06, 1993
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
Chemistry
112d
Cleared
Mar 27, 1992
AMYLASE REAGENT
Chemistry
22d
Cleared
Jul 01, 1991
AMYLASE REAGENT
Chemistry
25d
Cleared
May 22, 1991
HDL CHOLESTEROL REAGENT
Chemistry
54d