Medical Device Manufacturer · US , Newport Beach , CA

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

10 submissions · 10 cleared · Since 1991

Official Website

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomerica, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Dec 15, 2023

Hp Detect™ Stool Antigen ELISA

Microbiology · 88d

Cleared Mar 04, 1992

GAP IGG H.PYLORI MODIFIED

Microbiology · 107d

Cleared Aug 22, 1991

Microbiology · 576d