510(k) Report

FDA applicant

Biopool AB

Ontario, L7l 6b8, CA13 decisions1990–19951 recall

FDA records 13 decisions for Biopool AB (Ontario, L7l 6b8, CA) from 1990 to 1995: 13 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and GHH (Fibrin Split Products). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Biopool AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biopool AB since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biopool AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biopool AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GGPTest, Qualitative And Quantitative Factor Deficiency9decisions
  • GHHFibrin Split Products1decision
  • GIRReagent, Russel Viper Venom1decision
  • KFFAssay, Heparin1decision
  • JBQAntithrombin Iii Quantitation1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K934314Tintelizer (R) TpaBiopool AB · 19942cite it
  • K923499Spectrolyse Heparin KitBiopool AB · 19941cites it
  • K922782Spectrolyse/PL Pai KitBiopool AB · 19921cites it

What has FDA decided for it lately?

  • K941752Spectrolyse Antiplasmin KitBiopool AB · 1995
  • K942087Biopool VWF Eld Kit and VWF Eld Bulk PlatesBiopool AB · 1995
  • K934314Tintelizer (R) TpaBiopool AB · 1994
  • K923499Spectrolyse Heparin KitBiopool AB · 1994
  • K932463Bioclot LABiopool AB · 1993
  • K920668Minutex D-Dimer Latex TestBiopool AB · 19921 recall
  • K922782Spectrolyse/PL Pai KitBiopool AB · 1992
  • K915163Protein S Eid Kit and Protein S Eid Bulk PlatesBiopool AB · 1992

All 13 as Biopool AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K920668Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276…Jun 13, 2011

Other applicant names beginning “Biopool”

FDA records each applicant name separately; these may or may not be the same firm.

Biopool Intl., Inc. 4