# American Diagnostica, Inc.

- Location (FDA's records): Greenwich, CT
- FDA decisions: 10 (1994–2008): 10 510(k) clearances
- Product codes: GGP (4), KFF (2), DAP (1), GIR (1), GIZ (1), GJS (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Diagnostic Technologies, Inc.: 3 (https://510kreport.com/company/medical-diagnostic-technologies)
- Biopool AB: 3 (https://510kreport.com/company/biopool)
- Agen Biomedical, Ltd.: 1 (https://510kreport.com/company/agen-biomedical)

## Firms that cite its devices most
- R2 Diagnostics, Inc.: 1 (https://510kreport.com/company/r2-diagnostics)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma (1994), cited by 2
- K940490: DV Test and DVV Confirm (1995), cited by 1

## Recent decisions
- K080069: Dimertest (Feb 13, 2008)
- K063323: Spectrolyse Pai-1, Model 101201 (Aug 15, 2007)
- K052124: Acticlot, Model 824 (Oct 17, 2005)
- K013637: Actichrome Heparin (Anti-Fiia) (Apr 16, 2002)
- K013492: Imubind Tpa Elisa, Model 860 (Mar 13, 2002)
- K013318: Actichrome Heparin (Anti-Fxa), Model 832 (Mar 8, 2002)
- K013168: Imubind Plasma Pai-1 Elisa,Model 822 (Mar 7, 2002)
- K012386: Acticlot Protein S, Model 843L (Sep 14, 2001)

Source page: https://510kreport.com/company/american-diagnostica