FDA applicant

Genus Diagnostics

Woburn, MA9 decisions1985–19860 recalls

FDA records 9 decisions for Genus Diagnostics (Woburn, MA) from 1985 to 1986: 9 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and GQN (Antigen, Cf (Including Cf 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Genus Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Genus”

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

Genus Medical, Inc. 1

Genus Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Genus”