# Biomerica, Inc.

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 10 (1991–2023): 10 510(k) clearances
- Product codes: LYR (3), DDC (1), CDP (1), JHI (1), CEC (1), KLI (1), JLW (1), JNL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Meridian Bioscience, Inc.: 1 (https://510kreport.com/company/meridian-bioscience)

## Recent decisions
- K232892: Hp Detect™ Stool Antigen ELISA (Dec 15, 2023)
- K003856: EZ-HCG Urine (Pregnancy Test) (Feb 21, 2001)
- K982954: Free T4 Microwell Eia, Model #7019 (Sep 24, 1998)
- K962216: TSH (Microwell) Elisa (Sep 19, 1996)
- K960412: T-3 Microwell Eia Model 7013 (Mar 19, 1996)
- K954256: Anti-Tpo (Nov 27, 1995)
- K950588: T4 Microwell Eia (Enzyme IMMUNOASSAY0 (Jun 29, 1995)
- K936010: Thyroglobulin Autoantibody Enzyme Immunoassay (Jul 18, 1994)

Source page: https://510kreport.com/company/biomerica