# Precision Biologicals, Inc.

- Location (FDA's records): Dartmouth, Nova Scotia, CA
- FDA decisions: 20 (1989–1999): 20 510(k) clearances
- Product codes: GJT (7), GGN (6), JSM (2), GGC (2), GJS (1), GFO (1), GGW (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 6 (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
- Sigma Chemical Co.: 2 (https://510kreport.com/company/sigma-chemical)
- Bio/Data Corp.: 1 (https://510kreport.com/company/bio-data)

## Firms that cite its devices most
- Affinity Biologicals, Inc.: 2 (https://510kreport.com/company/affinity-biologicals)
- Diagnostica Stago, Inc.: 1 (https://510kreport.com/company/diagnostica-stago)
- Vital Scientific N.V.: 1 (https://510kreport.com/company/vital-scientific)
- George King Bio-Medical, Inc.: 1 (https://510kreport.com/company/george-king-bio-medical)
- Precision Biologic: 1 (https://510kreport.com/company/precision-biologic)

## Its most-cited devices
- K952622: Cryo Check Normal Human Reference Plasma (1995), cited by 2
- K952623: Cryo Check Lupus Plasma (1995), cited by 2
- K952624: Cryo Check Abnormal Reference Check I & II (1995), cited by 1
- K971219: Cryo Check Inr Validation Set (1997), cited by 1

## Recent decisions
- K981173: Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML) (Jan 13, 1999)
- K981174: Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML) (Jan 13, 1999)
- K982062: Cryo-Check PNP Platelet Lysate, Model PNP-10 (Jan 13, 1999)
- K971219: Cryo Check Inr Validation Set (Aug 29, 1997)
- K971222: Cryo Check Apc Resistant Plasma (Aug 19, 1997)
- K971223: Cryo Check Factor V Deficient Plasma (Jul 22, 1997)
- K971227: Cryo Check Factor X Deficient Plasma (Jul 18, 1997)
- K971226: Cryo Check Factor IX Deficient Plasma (Jul 18, 1997)

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