# Affinity Biologicals, Inc.

- Location (FDA's records): Ancaster, Ontario, CA
- FDA decisions: 5 (2005–2016): 5 510(k) clearances
- Product codes: GGN (3), GGP (2)
- Predicates its devices cite: 7 (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
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Precision Biologicals, Inc.: 2 (https://510kreport.com/company/precision-biologicals)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Precision Biologic: 1 (https://510kreport.com/company/precision-biologic)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)

## Recent decisions
- K150144: VisuCon-F Low Fibrinogen Control Plasma (Mar 6, 2016)
- K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (Oct 20, 2011)
- K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma (Oct 28, 2009)
- K052825: Visulize Factor Viii Antigen Kit, Model Fviii-AG (Jan 20, 2006)
- K051054: Visulize Factor IX Antigen Kit (Jun 29, 2005)

Source page: https://510kreport.com/company/affinity-biologicals