FDA applicant

Euroimmun Us, Inc.

Morris Plains, NJ37 decisions2006–20200 recalls

FDA records 37 decisions for Euroimmun Us, Inc. (Morris Plains, NJ) from 2006 to 2020: 36 510(k) clearances and 1 De Novo grant. Most are in product codes MOB (Test System, Antineutrophil Cytoplasmic…) and DHN (Antinuclear Antibody, Indirect…). Its devices cite 25 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Euroimmun US”, “Euroimmun Us, LLC”.

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 Euroimmun Us, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 6 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Euroimmun Us, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Euroimmun Us, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?