510(k) Report

FDA applicant

Biomedical Diagnostics (Bmd) SA

Marne La Vallee Cedex 2, FR10 decisions2005–20100 recalls

FDA records 10 decisions for Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR) from 2005 to 2010: 10 510(k) clearances. Most are in product codes MOB (Test System, Antineutrophil Cytoplasmic…) and LLL (Extractable Antinuclear Antibody, Antigen And…). Its devices cite 19 predicates, 4 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 (Bmd) SA’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007: 22010: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomedical Diagnostics (Bmd) SA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)3decisions
  • LLLExtractable Antinuclear Antibody, Antigen And Control3decisions
  • MSTAntibodies, Gliadin1decision
  • JZOSystem, Test, Thyroid Autoantibody1decision
  • LKOAnti-Rnp Antibody, Antigen And Control1decision
  • LSWAnti-Dna Antibody, Antigen And Control1decision

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 20062cite it
  • K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 20071cites it
  • K053012Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 20061cites it
  • K070458Modification to Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 20071cites it

What has FDA decided for it lately?

  • K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010
  • K100917Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA · 2010
  • K070458Modification to Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA · 2007
  • K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
  • K061794Fidis TM Thyro, Model MX002Biomedical Diagnostics (Bmd) SA · 2006
  • K060380Fidis DsdnaBiomedical Diagnostics (Bmd) SA · 2006
  • K053383Fidis CeliacBiomedical Diagnostics (Bmd) SA · 2006
  • K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006

All 10 as Biomedical Diagnostics (Bmd) SA →