510(k) Report

FDA applicant

Biomira Diagnostics, Inc.

Rexdale, Ontario, CA2 decisions1995–19960 recalls

FDA records 2 decisions for Biomira Diagnostics, Inc. (Rexdale, Ontario, CA) from 1995 to 1996: 2 510(k) clearances. Most are in product codes LIP (Enzyme Linked Immunoabsorption Assay…) and GMQ (Antigens, Nontreponemal, All). No 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, microbiology panel, where it files most

How often FDA has decided Biomira Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomira Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum1decision
  • GMQAntigens, Nontreponemal, All1decision

What has FDA decided for it lately?

  • K952802Visuwell Reagin IIBiomira Diagnostics, Inc. · 1996
  • K932453Visuwell Syphilis AntibodyBiomira Diagnostics, Inc. · 1995

All 2 as Biomira Diagnostics, Inc. →

Other applicant names beginning “Biomira”

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

Biomira USA, Inc. 1Biomira, Inc. 1