510(k) Report

FDA applicant

Murex Diagnostics Limitd

England, DE1 decision1995–19950 recalls

FDA records 1 decision for Murex Diagnostics Limitd (England, DE) in 1995: 1 510(k) clearance. All are in product code JWX (Kit, Screening, Staphylococcus Aureus). 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, microbiology panel, where it files most

How often FDA has decided Murex Diagnostics Limitd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Murex Diagnostics Limitd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Murex”

FDA records each applicant name separately; these may or may not be the same firm.