Bayer Corp. - FDA 510(k) Cleared Devices

Bayer Corp. is the American subsidiary of Bayer AG, headquartered in Whippany, New Jersey. The company operates 40 fully consolidated subsidiaries across 19 states.

Bayer Corp. received 96 FDA 510(k) clearances from 96 total submissions, with no denied submissions on record. The company's regulatory activity spans from 1989 to 2003, with a primary focus on chemistry devices and immunology assays. Notable cleared devices include the ASCENSIA BREEZE BLOOD GLUCOSE METER, CLINITEST PREGNANCY TEST, and the ADVIA CENTAUR immunoassay system. This represents a historical regulatory record; the company has not received clearances in more than 20 years.

Bayer Corp. specialized in diagnostic chemistry and immunoassay technologies for clinical laboratory use. The company's product portfolio included blood glucose monitoring systems, pregnancy testing, and modular immunoassay platforms for automated clinical analysis.

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