Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Genzyme Corp. — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

77 daysmedian FDA review time

185 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061508	OSOM INFLUENZA A&B TEST	Genzyme Corp.	2006-06-12	11	0
K051244	GENZYME OSOM INFLUENZA A & B TEST	Genzyme Corp.	2006-02-21	281	0
K040241	N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET	Genzyme Corp.	2004-06-25	143	0
K040868	SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH	Genzyme Corp.	2004-06-04	63	0
K033864	GENZYME OSOM TRICHOMONAS RAPID TEST	Genzyme Corp.	2004-04-02	112	0
K023544	GENZYME CONTRAST II HCG URINE/SERUM TEST	Genzyme Corp.	2003-01-16	86	0
K021316	ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-	Genzyme Corp.	2002-07-25	91	0
K021019	COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE	Genzyme Corp.	2002-06-18	81	7
K012532	SEPRAGEL SINUS	Genzyme Corp.	2001-10-30	85	0
K011843	GENZYME DIRECT-AMYLASE TEST REAGENT	Genzyme Corp.	2001-08-10	59	0
K000239	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPR	Genzyme Corp.	2000-03-21	54	0
K994328	SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX	Genzyme Corp.	2000-03-02	71	0
K992766	N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLE	Genzyme Corp.	1999-10-18	62	0
K993132	GENZYME DIRECT AMYLASE VERIFIER	Genzyme Corp.	1999-10-04	14	0
K983726	GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPR	Genzyme Corp.	1998-11-25	34	0
K971573	N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL	Genzyme Corp.	1997-06-18	49	0
K971162	LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR	Genzyme Corp.	1997-06-16	77	0
K971190	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	Genzyme Corp.	1997-06-16	77	0
K962186	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	Genzyme Corp.	1996-08-19	74	0
K954898	PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)	Genzyme Corp.	1996-02-05	138	0
K943150	DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT	Genzyme Corp.	1995-03-15	258	0
K933397	GENZYME A-AMYLASE TEST REAGENT	Genzyme Corp.	1993-10-28	108	0
K926390	PREDICTA ERYTHROPOIETIN KIT	Genzyme Corp.	1993-06-25	185	0
K924674	DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT	Genzyme Corp.	1993-01-06	112	0
K921057	AMYLASE REAGENT	Genzyme Corp.	1992-03-27	22	0
K912519	AMYLASE REAGENT	Genzyme Corp.	1991-07-01	25	0
K911406	HDL CHOLESTEROL REAGENT	Genzyme Corp.	1991-05-22	54	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda