510(k) Report

FDA applicant

Mercia Diagnostics, Ltd.

Guildford, Surrey England, GB17 decisions1987–19921 recall

FDA records 17 decisions for Mercia Diagnostics, Ltd. (Guildford, Surrey England, GB) from 1987 to 1992: 17 510(k) clearances. Most are in product codes LIP (Enzyme Linked Immunoabsorption Assay…) and LGD (Enzyme Linked Immunoabsorbent Assay…). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Mercia Diagnostics, Ltd. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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