FDA applicant

Biomerica, Inc.

Newport Beach, CA10 decisions1991–20230 recalls

FDA records 10 decisions for Biomerica, Inc. (Newport Beach, CA) from 1991 to 2023: 10 510(k) clearances. Most are in product codes LYR (Helicobacter Pylori) and DDC (Thyroglobulin, Antigen, Antiserum, Control). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Biomerica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Biomerica, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?