# R2 Diagnostics, Inc.

- Location (FDA's records): South Bend, IN
- FDA decisions: 10 (2004–2011): 10 510(k) clearances
- Product codes: GJT (2), GGW (2), GIR (1), GJA (1), GGP (1), GIS (1), GGC (1), GJS (1)
- Predicates its devices cite: 11 (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
- American Bioproducts Co.: 4 (https://510kreport.com/company/american-bioproducts)
- Medical Diagnostic Technologies, Inc.: 3 (https://510kreport.com/company/medical-diagnostic-technologies)
- Diagnostica Stago, Inc.: 1 (https://510kreport.com/company/diagnostica-stago)
- American Diagnostica, Inc.: 1 (https://510kreport.com/company/american-diagnostica)
- American Dade: 1 (https://510kreport.com/company/american-dade)
- Pacific Hemostasis: 1 (https://510kreport.com/company/pacific-hemostasis)

## Recent decisions
- K102851: Nofact Viii (Dec 19, 2011)
- K102908: Nofact IX (Dec 19, 2011)
- K090105: Lupotek KCT (Dec 30, 2010)
- K083878: Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA (Jun 25, 2010)
- K082631: Thrombo Tek Pse, Model 90-480 (Dec 17, 2008)
- K062306: Plasmacon N, Plasmacon L-1, Plasmacon L-2 (Mar 16, 2007)
- K050817: T-TEK (Dec 12, 2005)
- K042919: Fibrotek Fib (Nov 29, 2004)

Source page: https://510kreport.com/company/r2-diagnostics