FDA applicant

Genalyte, Inc.

San Diego, CA2 decisions2019–20240 recalls

FDA records 2 decisions for Genalyte, Inc. (San Diego, CA) from 2019 to 2024: 2 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and LKO (Anti-Rnp 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2024

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Genalyte, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Genalyte, Inc.

Which product codes does it file in?

What has FDA decided for it lately?