# Precision Biologic

- Location (FDA's records): Dartmouth, N.S., CA
- FDA decisions: 17 (1999–2025): 17 510(k) clearances
- Names in FDA's records: Precision Biologic (10); Precision Biologic, Inc. (7)
- Product codes: GGP (7), GJT (3), GIR (2), GIZ (1), GGC (1), JBQ (1), GGW (1), GFO (1)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 4 (1 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: 4 (https://510kreport.com/company/instrumentation-laboratory)
- American Bioproducts Co.: 3 (https://510kreport.com/company/american-bioproducts)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Chromogenix AB: 1 (https://510kreport.com/company/chromogenix)
- Precision Biologicals, Inc.: 1 (https://510kreport.com/company/precision-biologicals)
- Sigma Chemical Co.: 1 (https://510kreport.com/company/sigma-chemical)
- Gradipore, Ltd.: 1 (https://510kreport.com/company/gradipore)
- Genetic Testing Institute: 1 (https://510kreport.com/company/genetic-testing-institute)

## Firms that cite its devices most
- Horiba Abx: 2 (https://510kreport.com/company/horiba-abx)
- Affinity Biologicals, Inc.: 1 (https://510kreport.com/company/affinity-biologicals)

## Its most-cited devices
- K193204: Cryocheck Chromogenic Factor VIII (2020), cited by 1
- K013708: Reference Check, Catalog Number-RCN-10 (2001), cited by 1
- K023990: Chromocheck Protein C 25; Chromocheck Protein C 50 (2003), cited by 1
- K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 (2003), cited by 1

## Recent decisions
- K251440: CRYOcheck Chromogenic Factor VIII (Aug 25, 2025)
- K222831: CRYOcheck Factor VIII Deficient Plasma with VWF (Sep 13, 2023)
- K214002: CRYOcheck Chromogenic Factor IX (Dec 23, 2022)
- K193556: Cryocheck Hex LA (Oct 23, 2020)
- K193204: Cryocheck Chromogenic Factor VIII (Jul 17, 2020)
- K183440: CRYOcheck FVIII Inhibitor Kit (Mar 12, 2019)
- K060284: Cryocheck Clot Apcr (May 10, 2006)
- K043571: Cryocheck Clot S (Mar 18, 2005)

Source page: https://510kreport.com/company/precision-biologic