FDA 510(k) Applications Submitted by GENZYME CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K954898 09/20/1995 PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) GENZYME CORP.
K021316 04/25/2002 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR GENZYME CORP.
K000239 01/27/2000 GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL GENZYME CORP.
K011843 06/12/2001 GENZYME DIRECT-AMYLASE TEST REAGENT GENZYME CORP.
K992766 08/17/1999 N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET GENZYME CORP.
K993132 09/20/1999 GENZYME DIRECT AMYLASE VERIFIER GENZYME CORP.
K983726 10/22/1998 GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL GENZYME CORP.
K023544 10/22/2002 GENZYME CONTRAST II HCG URINE/SERUM TEST GENZYME CORP.
K033864 12/12/2003 GENZYME OSOM TRICHOMONAS RAPID TEST GENZYME CORP.
K040241 02/03/2004 N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET GENZYME CORP.
K051244 05/16/2005 GENZYME OSOM INFLUENZA A & B TEST GENZYME CORP.
K061508 06/01/2006 OSOM INFLUENZA A&B TEST GENZYME CORP.
K994328 12/22/1999 SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX GENZYME CORP.
K021019 03/29/2002 COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE GENZYME CORP.
K040868 04/02/2004 SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH GENZYME CORP.
K012532 08/06/2001 SEPRAGEL SINUS GENZYME CORP.
K971162 03/31/1997 LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR GENZYME CORP.
K971190 03/31/1997 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR GENZYME CORP.
K971573 04/30/1997 N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET GENZYME CORP.
K962186 06/06/1996 N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR GENZYME CORP.


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