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Genzyme Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061508OSOM INFLUENZA A&B TESTJune 12, 2006
K051244GENZYME OSOM INFLUENZA A & B TESTFebruary 21, 2006
K040241N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SETJune 25, 2004
K040868SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESHJune 4, 2004
K033864GENZYME OSOM TRICHOMONAS RAPID TESTApril 2, 2004
K023544GENZYME CONTRAST II HCG URINE/SERUM TESTJanuary 16, 2003
K021316ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATORJuly 25, 2002
K021019COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTUREJune 18, 2002
K012532SEPRAGEL SINUSOctober 30, 2001
K011843GENZYME DIRECT-AMYLASE TEST REAGENTAugust 10, 2001
K000239GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROLMarch 21, 2000
K994328SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXXMarch 2, 2000
K992766N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROctober 18, 1999
K993132GENZYME DIRECT AMYLASE VERIFIEROctober 4, 1999
K983726GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROLNovember 25, 1998
K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONJune 18, 1997
K971162LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATORJune 16, 1997
K971190N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATORJune 16, 1997
K962186N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATORAugust 19, 1996
K954898PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)February 5, 1996