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Genzyme Diagnostics P.E.I., Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K081938 ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30LDP2009-05-01 View
510(k) K082210 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30CIG2008-12-16 View
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