FDA applicant
Boots-Celltech Diagnostics, Inc.
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
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.
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