Biomerica, Inc. - FDA 510(k) Cleared Devices

Biomerica, Inc. is a global biomedical technology company developing, manufacturing, and marketing advanced in-vitro diagnostic products. Headquartered in Irvine, California, the company operates FDA and CE registered manufacturing facilities in California and Mexico, specializing in gastrointestinal and inflammatory disease diagnostics.

Biomerica has received 10 FDA 510(k) clearances from 10 total submissions since 1991. The company's cleared devices span chemistry, microbiology, and immunology categories, including pregnancy tests, thyroid function assays, H. pylori detection, and autoantibody immunoassays. The latest clearance was issued in 2023, reflecting the company's sustained regulatory engagement over three decades.

The company's product portfolio encompasses clinical laboratory ELISA systems, point-of-care rapid tests, and at-home diagnostic solutions. Biomerica also provides contract manufacturing services for multinational pharmaceutical and diagnostic organizations. The company maintains a distinguished scientific advisory board and operates under EN ISO 13485:2016 certification for quality management.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.