510(k) Report

FDA applicant

Biomira USA, Inc.

Cranberry, NJ1 decision1997–19970 recalls

FDA records 1 decision for Biomira USA, Inc. (Cranberry, NJ) in 1997: 1 510(k) clearance. All are in product code MOI (System, Test, Immunological, Antigen, Tumor). 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 USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomira USA, 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?

  • MOISystem, Test, Immunological, Antigen, Tumor1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K965141Truquant BR RiaBiomira USA, Inc. · 19971cites it

What has FDA decided for it lately?

  • K965141Truquant BR RiaBiomira USA, Inc. · 1997

The one decision as Biomira USA, 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, Inc. 1