FDA applicant

Alfa Biotech (Uk), Ltd.

Aldershot, GB3 decisions1998–19980 recalls

FDA records 3 decisions for Alfa Biotech (Uk), Ltd. (Aldershot, GB) in 1998: 3 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and CDP (Radioimmunoassay, Total Triiodothyronine). 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, clinical chemistry panel, where it files most

How often FDA has decided Alfa Biotech (Uk), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alfa Biotech (Uk), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Alfa”

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

Alfa Scientific Designs, Inc. 44 Alfa Wassermann Diagnostic Technologies, Inc. 23 Alfa Wassermann, Inc. 9 Alfa Wassermann Diagnostics Technologies, LLC 3 Alfa Tech Medical Systems, Ltd. 2 Alfa Technologies, Inc. 1 Alfa Thermodiagnostics, Inc. 1 Alfa Gate Mazen, Ltd. 1

Alfa Biotech (Uk), Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Alfa”