510(k) Report

FDA applicant

European Concerted Action on Anticoagulation

Manchester, GB1 decision1999–19990 recalls

FDA records 1 decision for European Concerted Action on Anticoagulation (Manchester, GB) in 1999: 1 510(k) clearance. All are in product code GGN (Plasma, Coagulation Control). 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, hematology panel, where it files most

How often FDA has decided European Concerted Action on Anticoagulation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for European Concerted Action on Anticoagulation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — European Concerted Action on Anticoagulation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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