INFINITI CYP2C19 ASSAY

INFINITI CYP2C19 ASSAY is an FDA 510(k)-cleared medical device (K101683) manufactured by Autogenomics, Incorporated. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2010. Regulation: 8.