Genzyme Corp.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K061508	OSOM INFLUENZA A&B TEST	PSZ	2006-06-12	View
510(k)	K051244	GENZYME OSOM INFLUENZA A & B TEST	PSZ	2006-02-21	View
510(k)	K040241	N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET	DCK	2004-06-25	View
510(k)	K040868	SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH	FTM	2004-06-04	View
510(k)	K033864	GENZYME OSOM TRICHOMONAS RAPID TEST	JWZ	2004-04-02	View
510(k)	K023544	GENZYME CONTRAST II HCG URINE/SERUM TEST	JHI	2003-01-16	View
510(k)	K021316	ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR	LBS	2002-07-25	View
510(k)	K021019	COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE	GAT	2002-06-18	View
510(k)	K012532	SEPRAGEL SINUS	LYA	2001-10-30	View
510(k)	K011843	GENZYME DIRECT-AMYLASE TEST REAGENT	JFJ	2001-08-10	View
510(k)	K000239	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL	LCP	2000-03-21	View
510(k)	K994328	SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX	FTL	2000-03-02	View
510(k)	K992766	N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET	MRR	1999-10-18	View
510(k)	K993132	GENZYME DIRECT AMYLASE VERIFIER	JIT	1999-10-04	View
510(k)	K983726	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL	LCP	1998-11-25	View
510(k)	K971573	N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET	LBR	1997-06-18	View
510(k)	K971190	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	LBS	1997-06-16	View
510(k)	K971162	LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR	LBS	1997-06-16	View
510(k)	K962186	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	LBR	1996-08-19	View
510(k)	K954898	PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)	GGT	1996-02-05	View