FDA applicant

Cogent Diagnotics, Ltd.

Midlothian, Scotland, GB31 decisions1992–20002 recalls

FDA records 31 decisions for Cogent Diagnotics, Ltd. (Midlothian, Scotland, GB) from 1992 to 2000: 31 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and MID (System, Test, Anticardiolipin Immunological). 2 recalls are 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 Cogent Diagnotics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cogent Diagnotics, Ltd. since 2007.

Recalls per year

2in 2018

2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Cogent”

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

Cogent Light Technologies, Inc. 5 Cogent Spine, LLC 3 Cogent Therapeutics, LLC 1 Cogent 1

Cogent Diagnotics, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cogent”