FDA applicant

Diatech Diagnostica, Ltd.

Washington, DC3 decisions1988–19890 recalls

FDA records 3 decisions for Diatech Diagnostica, Ltd. (Washington, DC) from 1988 to 1989: 3 510(k) clearances. Most are in product codes LJZ (Enzyme Linked Immunoabsorbent Assay…) and JXA (Kit, Screening, Urine). 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 Diatech Diagnostica, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diatech Diagnostica, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Diatech Diagnostica, 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 “Diatech”

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

Diatech, Inc. 17 Diatech Diagnostics,Inc. 1

Diatech Diagnostica, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Diatech”