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Genzyme Corp.

27 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
OSOM INFLUENZA A&B TEST (K061508)Genzyme Corp.2006-06-12
GENZYME OSOM INFLUENZA A & B TEST (K051244)Genzyme Corp.2006-02-21
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (K040241)Genzyme Corp.2004-06-25
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (K040868)Genzyme Corp.2004-06-04
GENZYME OSOM TRICHOMONAS RAPID TEST (K033864)Genzyme Corp.2004-04-02
GENZYME CONTRAST II HCG URINE/SERUM TEST (K023544)Genzyme Corp.2003-01-16
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316)Genzyme Corp.2002-07-25
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (K021019)Genzyme Corp.2002-06-18
SEPRAGEL SINUS (K012532)Genzyme Corp.2001-10-30
GENZYME DIRECT-AMYLASE TEST REAGENT (K011843)Genzyme Corp.2001-08-10
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K000239)Genzyme Corp.2000-03-21
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX (K994328)Genzyme Corp.2000-03-02
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K992766)Genzyme Corp.1999-10-18
GENZYME DIRECT AMYLASE VERIFIER (K993132)Genzyme Corp.1999-10-04
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K983726)Genzyme Corp.1998-11-25
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K971573)Genzyme Corp.1997-06-18
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR (K971162)Genzyme Corp.1997-06-16
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K971190)Genzyme Corp.1997-06-16
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K962186)Genzyme Corp.1996-08-19
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898)Genzyme Corp.1996-02-05
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT (K943150)Genzyme Corp.1995-03-15
GENZYME A-AMYLASE TEST REAGENT (K933397)Genzyme Corp.1993-10-28
PREDICTA ERYTHROPOIETIN KIT (K926390)Genzyme Corp.1993-06-25
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT (K924674)Genzyme Corp.1993-01-06
AMYLASE REAGENT (K921057)Genzyme Corp.1992-03-27
AMYLASE REAGENT (K912519)Genzyme Corp.1991-07-01
HDL CHOLESTEROL REAGENT (K911406)Genzyme Corp.1991-05-22

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