510(k) Report

FDA applicant

Biomira, Inc.

Rexdale, Ontario1 decision1996–19960 recalls

FDA records 1 decision for Biomira, Inc. (Rexdale, Ontario) in 1996: 1 original PMA approval. All are in product code MJB (Antigen, Cancer 549). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Biomira, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomira, 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?

  • MJBAntigen, Cancer 5491decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • P950011Truquant (R) BR (TM) RiaBiomira, Inc. · 19962cite it

What has FDA decided for it lately?

  • P950011Truquant (R) BR (TM) RiaBiomira, Inc. · 1996

The one decision as Biomira, Inc. →

Other applicant names beginning “Biomira”

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

Biomira Diagnostics, Inc. 2Biomira USA, Inc. 1