510(k) Report

FDA applicant

Eurodiagnostica

Frederick, MD3 decisions2005–20050 recalls

FDA records 3 decisions for Eurodiagnostica (Frederick, MD) in 2005: 3 510(k) clearances. Most are in product codes MOB (Test System, Antineutrophil Cytoplasmic…) and NHX (Antibodies, Anti-Cyclic Citrullinated Peptide…). 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 Eurodiagnostica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eurodiagnostica since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eurodiagnostica 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?

  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)2decisions
  • NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K052133Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 20054cite it

What has FDA decided for it lately?

  • K052133Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
  • K051455Wieslab Cap Mpo-AncaEurodiagnostica · 2005
  • K051458Wieslab Cap PR-3 AncaEurodiagnostica · 2005

All 3 as Eurodiagnostica →