510(k) Report

FDA applicant

Euro-Diagnostica AB

Ringoes, NJ6 decisions1997–20101 recall

FDA records 6 decisions for Euro-Diagnostica AB (Ringoes, NJ) from 1997 to 2010: 6 510(k) clearances. Most are in product codes NHX (Antibodies, Anti-Cyclic Citrullinated Peptide…) and MOB (Test System, Antineutrophil Cytoplasmic…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Euro-Diagnostica AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Euro-Diagnostica AB 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?

  • NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)3decisions
  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)2decisions
  • DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control1decision

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?

  • K093908CcpointEuro-Diagnostica AB · 2010
  • K091657Immunoscan CcplusEuro-Diagnostica AB · 20091 recall
  • K062045Edia Anti-CCPEuro-Diagnostica AB · 2006
  • K971464Immunoscan Anti-GBM Quantitative KitEuro-Diagnostica AB · 1997
  • K971690Immunoscan PR3-AncaEuro-Diagnostica AB · 1997
  • K971689Immunoscan Anti-Myeloperoxidase Antibodies (Mpo-Anca) Quantitative KitEuro-Diagnostica AB · 1997

All 6 as Euro-Diagnostica AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091657Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for…Feb 14, 2016Class II