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Genzyme Diagnostics

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K043385 OSOM HCG COMBO TESTJHI2005-04-12 View
510(k) K983399 GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYMHI1999-01-11 View
510(k) K963425 GENZYME DIAGNOSTICS CONTRAST MONOKTN1997-02-25 View
510(k) K964156 CONTRAST STRIP HCGJHI1996-11-25 View
510(k) K964155 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TESTJHI1996-11-25 View
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