510(k) Report

FDA applicant

Boots-Celltech Diagnostics, Inc.

Berkshire, England, GB20 decisions1984–19890 recalls

FDA records 20 decisions for Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB) from 1984 to 1989: 20 510(k) clearances. Most are in product codes LJC (Enzyme Linked Immunoabsorbent Assay…) and CEP (Radioimmunoassay, Luteinizing 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, microbiology panel, where it files most

How often FDA has decided Boots-Celltech Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boots-Celltech Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Boots-Celltech Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report