# Biopool AB

- Location (FDA's records): Ontario, L7l 6b8, CA
- FDA decisions: 13 (1990–1995): 13 510(k) clearances
- Product codes: GGP (9), GHH (1), GIR (1), KFF (1), JBQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- American Diagnostica, Inc.: 3 (https://510kreport.com/company/american-diagnostica)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)

## Its most-cited devices
- K934314: Tintelizer (R) Tpa (1994), cited by 2
- K923499: Spectrolyse Heparin Kit (1994), cited by 1
- K922782: Spectrolyse/PL Pai Kit (1992), cited by 1

## Recent decisions
- K941752: Spectrolyse Antiplasmin Kit (Sep 25, 1995)
- K942087: Biopool VWF Eld Kit and VWF Eld Bulk Plates (Jul 13, 1995)
- K934314: Tintelizer (R) Tpa (Feb 23, 1994)
- K923499: Spectrolyse Heparin Kit (Jan 27, 1994)
- K932463: Bioclot LA (Sep 27, 1993)
- K920668: Minutex D-Dimer Latex Test (Oct 16, 1992)
- K922782: Spectrolyse/PL Pai Kit (Oct 9, 1992)
- K915163: Protein S Eid Kit and Protein S Eid Bulk Plates (Jan 6, 1992)

Source page: https://510kreport.com/company/biopool