Bio-Rad Laboratories, Inc. - FDA 510(k) Cleared Devices

Bio-Rad Laboratories, Inc. is an American developer and manufacturer of specialized technological products for life science research and clinical diagnostics. Founded in 1952 in Berkeley, California, the company is based in Hercules, California, with operations worldwide.

Bio-Rad has received 82 FDA 510(k) clearances from 82 total submissions between 1991 and 2019. The company's regulatory record reflects a strong focus on chemistry devices, including hemoglobin testing systems, quality control materials, and diagnostic assays. Additional cleared devices span immunology, hematology, medical genetics, and microbiology categories.

This regulatory record is presented as a historical account. The company has not received FDA 510(k) clearances in more than five years and should be treated as an inactive submission record.

Explore the complete list of device names, product codes, and clearance dates in the database to review Bio-Rad's full regulatory history.