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FDA 510(k) Applications Submitted by GENZYME DIAGNOSTICS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K983399
09/28/1998
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
GENZYME DIAGNOSTICS
K964155
10/16/1996
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
GENZYME DIAGNOSTICS
K964156
10/16/1996
CONTRAST STRIP HCG
GENZYME DIAGNOSTICS
K963425
08/30/1996
GENZYME DIAGNOSTICS CONTRAST MONO
GENZYME DIAGNOSTICS
K043385
12/09/2004
OSOM HCG COMBO TEST
GENZYME DIAGNOSTICS
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