Cardiovascular Diagnostics, Inc. is one of 13016 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cardiovascular Diagnostics, Inc. - FDA 510(k) Cleared Devices
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
Cardiovascular Diagnostics, Inc. has 13 FDA 510(k) cleared hematology devices. Based in Raleigh, US.
Historical record: 13 cleared submissions from 1995 to 2002.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Cardiovascular Diagnostics, Inc.
13 devices
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