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Autogenomics, Incorporated
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INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN is an FDA 510(k)-cleared medical device (K073014) 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 January 22, 2008. Regulation: 8.