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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