Hycor Biomedical, Inc. - FDA 510(k) Cleared Devices

Hycor Biomedical, Inc. is an American manufacturer of in vitro diagnostic products for blood testing. The company is based in Garden Grove, California and specializes in allergy and autoimmune testing solutions.

Hycor Biomedical has received 51 FDA 510(k) clearances from 51 total submissions since its first clearance in 1989. The company's regulatory portfolio is dominated by Immunology devices, which represent the majority of its cleared submissions. The latest FDA 510(k) clearance on record dates to 2008, reflecting the company's historical significance in the diagnostic device sector.

The company's cleared devices include automated immunoassay systems and enzyme immunoassay platforms for detecting allergen-specific immunoglobulin E and autoimmune markers. Notable products include the HY-TEC system for specific and total IgE testing and the AUTOSTAT II line for anti-body detection. These systems have served clinical laboratories globally for allergy and autoimmune diagnostics.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.