Bio-Rad Laboratories - FDA 510(k) Cleared Devices

Bio-Rad Laboratories, is an American biotechnology firm founded in 1952 in Berkeley, California. The company develops and manufactures specialized products for life science research and clinical diagnostics, with operations worldwide.

Bio-Rad has received 45 FDA 510(k) clearances from 46 total submissions between 2007 and 2019. The company's cleared devices span chemistry devices, microbiology, and immunology categories, with notable focus on diagnostic control materials and multiplex immunoassay systems. This regulatory record reflects the company's historical activity in the clinical diagnostics market.

Bio-Rad's cleared device portfolio includes control materials for tumor markers, cardiac markers, and maternal serum testing, as well as multiplex immunoassay kits for infectious disease serology and vitamin D measurement. These products support laboratory quality assurance and clinical diagnostic workflows across multiple specialties.

Explore the complete list of device names, product codes, and individual clearance dates in the database records below.