Medical Device Manufacturer · US , Raleigh , NC

Cardiovascular Diagnostics, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1995

Recent clearances: (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT, HMP CONTROLS (TAS) RAPIDPOINT, RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiovascular Diagnostics, Inc. Hematology ✕

13 devices

1-13 of 13

Cleared Aug 23, 2002

ENOXAPARIN TEST CARD

Hematology · 323d

Cleared Mar 28, 2000

(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT

Hematology · 106d

Cleared Feb 15, 2000

HMP CONTROLS (TAS) RAPIDPOINT

Hematology · 68d

Cleared Jan 14, 2000

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST,...

Hematology · 88d

Cleared May 14, 1999

TAS ANALYZER, MODEL 1009

Hematology · 81d

Cleared May 26, 1998

TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)

Hematology · 55d

Cleared Apr 27, 1998

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

Hematology · 26d

Cleared May 29, 1997

TAS PT-NCTEST CONTROLS

Hematology · 17d

Cleared Aug 13, 1996

THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS

Hematology · 95d

Cleared Jun 05, 1996

TAS A PTT TEST CONTROLS

Hematology · 71d

Cleared May 30, 1996

TAS HMT CONTROLS

Hematology · 134d

Cleared Mar 11, 1996

PROTHROMBIN TIME TEST CARD

Hematology · 166d

Cleared May 10, 1995

HEPARIN MANAGEMENT TEST CARD

Hematology · 307d