Medical Device Manufacturer · US , Raleigh , NC

Cardiovascular Diagnostics, Inc.

13 submissions · 13 cleared · Since 1995
13
Total
13
Cleared
0
Denied

Cardiovascular Diagnostics, Inc. — FDA 510(k) Submissions

Cardiovascular Diagnostics, Inc. has submitted 13 FDA 510(k) premarket notifications since 1995, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plasma, Coagulation Control, Assay, Heparin, Test, Time, Prothrombin, Plasma, Control, Normal, Instrument, Coagulation, Automated . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
ENOXAPARIN TEST CARD
K013305 · KFF Assay, Heparin · Hematology
Aug 2002 323d
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · JBP Activated Whole Blood... · Hematology
Mar 2000 106d
HMP CONTROLS (TAS) RAPIDPOINT
K994159 · GGN Plasma, Coagulation Control · Hematology
Feb 2000 68d
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · JOX Analyzer, Heparin, Automated · Hematology
Jan 2000 88d
TAS ANALYZER, MODEL 1009
K990566 · JPA System, Multipurpose For... · Hematology
May 1999 81d
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
K981206 · GKP Instrument, Coagulation,... · Hematology
May 1998 55d
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
K981178 · GGN Plasma, Coagulation Control · Hematology
Apr 1998 26d
TAS PT-NCTEST CONTROLS
K971748 · GGN Plasma, Coagulation Control · Hematology
May 1997 17d
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
K961814 · GIZ Plasma, Control, Normal · Hematology
Aug 1996 95d
TAS A PTT TEST CONTROLS
K961189 · GGN Plasma, Coagulation Control · Hematology
Jun 1996 71d
TAS HMT CONTROLS
K960234 · GGN Plasma, Coagulation Control · Hematology
May 1996 134d
PROTHROMBIN TIME TEST CARD
K954625 · GJS Test, Time, Prothrombin · Hematology
Mar 1996 166d
HEPARIN MANAGEMENT TEST CARD; HMT CARD
K943283 · KFF Assay, Heparin · Hematology
May 1995 307d
Filters
All13 Hematology 13