FDA 510(k) Applications Submitted by CARDIOVASCULAR DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960234 |
01/17/1996 |
TAS HMT CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K981178 |
04/01/1998 |
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K954625 |
09/27/1995 |
PROTHROMBIN TIME TEST CARD |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K981206 |
04/01/1998 |
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K961189 |
03/26/1996 |
TAS A PTT TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K961814 |
05/10/1996 |
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K971748 |
05/12/1997 |
TAS PT-NCTEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K990566 |
02/22/1999 |
TAS ANALYZER, MODEL 1009 |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K013305 |
10/04/2001 |
ENOXAPARIN TEST CARD |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K993519 |
10/18/1999 |
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K994159 |
12/09/1999 |
HMP CONTROLS (TAS) RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
| K994194 |
12/13/1999 |
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
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