FDA applicant

Euro-Diagnostics BV

Old Greenwich, CT5 decisions1984–19850 recalls

FDA records 5 decisions for Euro-Diagnostics BV (Old Greenwich, CT) from 1984 to 1985: 5 510(k) clearances. Most are in product codes CEP (Radioimmunoassay, Luteinizing Hormone) and CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). 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, clinical chemistry panel, where it files most

How often FDA has decided Euro-Diagnostics BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Euro-Diagnostics BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Euro-Diagnostics BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Euro-Diagnostics BV

Which product codes does it file in?

What has FDA decided for it lately?