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

Diazyme Laboratories, Inc. develops innovative clinical diagnostic reagents using proprietary enzyme and immunoassay technologies. Founded in 2000, the company specializes in diagnostic tests for cardiovascular disease, cancer, liver disease, renal disease, diabetes, sepsis, inflammatory disease, vitamins, and electrolytes. Diazyme operates a cGMP and ISO 13485 certified manufacturing facility in Poway, California, with additional operations in Europe and Shanghai.

The company has received 10 FDA 510(k) clearances from 10 total submissions since 2018. Diazyme's cleared devices span immunology and chemistry platforms, including assays for free light chains, immunoglobulins, metabolites, and cardiac biomarkers. The most recent clearance was in 2026, demonstrating continued regulatory activity and product innovation.

Diazyme's product portfolio emphasizes chemiluminescent immunoassay (CLIA) and latex-enhanced immunoturbidimetric technologies. The company manufactures diagnostic reagents compatible with most automated chemistry and immunoassay analyzers, alongside proprietary instruments such as the DZ-Lite c270 analyzer. Products address clinically unmet diagnostic needs across multiple therapeutic areas.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the regulatory database.