510(k) Report

FDA applicant

Biomedical Diagnostics S.A.

Marne-La-Vallee, Cedex 2, FR1 decision2004–20040 recalls

FDA records 1 decision for Biomedical Diagnostics S.A. (Marne-La-Vallee, Cedex 2, FR) in 2004: 1 510(k) clearance. All are in product code MST (Antibodies, Gliadin). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Biomedical Diagnostics S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomedical Diagnostics S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomedical Diagnostics S.A. 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?

  • MSTAntibodies, Gliadin1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K041002Fidis CeliacBiomedical Diagnostics S.A. · 2004

The one decision as Biomedical Diagnostics S.A. →