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Cardiovascular Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K013305ENOXAPARIN TEST CARDAugust 23, 2002
K994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTMarch 28, 2000
K994159HMP CONTROLS (TAS) RAPIDPOINTFebruary 15, 2000
K993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESJanuary 14, 2000
K990566TAS ANALYZER, MODEL 1009May 14, 1999
K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)May 26, 1998
K981178THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLSApril 27, 1998
K971748TAS PT-NCTEST CONTROLSMay 29, 1997
K961814THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLSAugust 13, 1996
K961189TAS A PTT TEST CONTROLSJune 5, 1996
K960234TAS HMT CONTROLSMay 30, 1996
K954625PROTHROMBIN TIME TEST CARDMarch 11, 1996
K943283HEPARIN MANAGEMENT TEST CARD; HMT CARDMay 10, 1995