Genzyme Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K043385OSOM HCG COMBO TESTApril 12, 2005
K983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYJanuary 11, 1999
K963425GENZYME DIAGNOSTICS CONTRAST MONOFebruary 25, 1997
K964155CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TESTNovember 25, 1996
K964156CONTRAST STRIP HCGNovember 25, 1996