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Genchem, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K090283 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3JIX2009-06-05 View
510(k) K040977 GENCHEM ELECTROLYTE BUFFERJGS2004-12-27 View
510(k) K040972 CALCIUM, AZO DYE REAGENTCJY2004-12-27 View
510(k) K040973 BUN REAGENTCDS2004-12-27 View
510(k) K040975 GENCHEM CO2 ACID REAGENTJFL2004-12-27 View
510(k) K040974 GLUCOSE OXIDASE, GLUCOSECGA2004-12-27 View
510(k) K040976 GENCHEM CREATININE REAGENTCGX2004-12-27 View
510(k) K040971 GENCHEM ISE ELECTROLYTE REFERENCEJGS2004-12-22 View
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