FDA applicant

Immunodiagnostics, Ltd.

England, U.K., GB1 decision1987–19870 recalls

FDA records 1 decision for Immunodiagnostics, Ltd. (England, U.K., GB) in 1987: 1 510(k) clearance. All are in product code LSW (Anti-Dna Antibody, Antigen And Control). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Immunodiagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Immunodiagnostics, Ltd.’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

Other applicant names beginning “Immunodiagnostics”

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

Immunodiagnostics Systems Limited 1

Immunodiagnostics, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Immunodiagnostics”