510(k) Report

FDA applicant

Dakocytomation, Ltd.

Ely, Cambridgeshire, GB1 decision2004–20040 recalls

FDA records 1 decision for Dakocytomation, Ltd. (Ely, Cambridgeshire, GB) in 2004: 1 510(k) clearance. All are in product code LJC (Enzyme Linked Immunoabsorbent Assay…). 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 Dakocytomation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dakocytomation, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Dakocytomation”

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