# Cardiovascular Diagnostics, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 13 (1995–2002): 13 510(k) clearances
- Product codes: GGN (5), KFF (2), GIZ (1), GKP (1), GJS (1), JOX (1), JBP (1), JPA (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardiovascular Diagnostic Services: 2 (https://510kreport.com/company/cardiovascular-diagnostic-services)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)
- Hemotech, Inc.: 1 (https://510kreport.com/company/hemotech)

## Recent decisions
- K013305: Enoxaparin Test Card (Aug 23, 2002)
- K994194: (Tas) Low Range Heparin Management Card Rapidpoint (Mar 28, 2000)
- K994159: HMP Controls (Tas) Rapidpoint (Feb 15, 2000)
- K993519: Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test (Jan 14, 2000)
- K990566: Tas Analyzer, Model 1009 (May 14, 1999)
- K981206: Tas Results Data Acquisition System (Traqs) (May 26, 1998)
- K981178: Thrombolytic Assessment System Low Range Heparin Management Test Controls (Apr 27, 1998)
- K971748: Tas PT-Nctest Controls (May 29, 1997)

Source page: https://510kreport.com/company/cardiovascular-diagnostics