
Immunalysis Corporation
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IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K131168) manufactured by Immunalysis Corporation. 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 16, 2014. Regulation: 8.