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Casco Standards

FDA 510(k) & PMA Approved Devices — 38 products

Total Devices38
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K981436 DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109JIX1998-04-24 View
510(k) K972904 DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLJJY1998-02-20 View
510(k) K962629 DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORJIX1996-09-13 View
510(k) K962630 DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLJJY1996-07-22 View
510(k) K961750 DOCUMENT CARDIAC ASSAYED CONTROLJJY1996-07-22 View
510(k) K960244 DOCUMENT TDM ULTRA ASSAYED CONTROLDIF1996-03-22 View
510(k) K955155 DOCUMENT TDM ULTRA UNASSAYED CONTROLDIF1995-12-20 View
510(k) K950469 DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SETJJY1995-04-11 View
510(k) K945718 DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SETJJX1995-01-17 View
510(k) K945315 DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROLJJY1994-12-09 View
510(k) K944361 DOCUMENT R AMMONIA/ETHANOL CONTROLJJX1994-11-30 View
510(k) K944639 DOCUMENTR AMMONIA/ETHANOLCALIBRATORJIX1994-11-15 View
510(k) K944338 DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SETJJX1994-11-15 View
510(k) K940568 DOCUMENT(R) ZEROJJX1994-04-05 View
510(k) K932870 DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SETJJX1993-08-02 View
510(k) K932458 DOCUMENT ENZYMEJJY1993-06-29 View
510(k) K931139 DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SETJJY1993-05-12 View
510(k) K924493 DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MODJJX1993-01-11 View
510(k) K923794 DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SETJJX1992-11-05 View
510(k) K923793 DOCUMENT CHEM III CALIBRATION VERIFICATION TESTJJX1992-11-05 View
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