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Cardiovascular Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K013305 ENOXAPARIN TEST CARDKFF2002-08-23 View
510(k) K994194 (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTJBP2000-03-28 View
510(k) K994159 HMP CONTROLS (TAS) RAPIDPOINTGGN2000-02-15 View
510(k) K993519 RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTJOX2000-01-14 View
510(k) K990566 TAS ANALYZER, MODEL 1009JPA1999-05-14 View
510(k) K981206 TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)GKP1998-05-26 View
510(k) K981178 THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLSGGN1998-04-27 View
510(k) K971748 TAS PT-NCTEST CONTROLSGGN1997-05-29 View
510(k) K961814 THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLSGIZ1996-08-13 View
510(k) K961189 TAS A PTT TEST CONTROLSGGN1996-06-05 View
510(k) K960234 TAS HMT CONTROLSGGN1996-05-30 View
510(k) K954625 PROTHROMBIN TIME TEST CARDGJS1996-03-11 View
510(k) K943283 HEPARIN MANAGEMENT TEST CARD; HMT CARDKFF1995-05-10 View
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