ORAL THC-CANNABINOIDS DIRECT RIA KIT

ORAL THC-CANNABINOIDS DIRECT RIA KIT is an FDA 510(k)-cleared medical device (K821965) 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 July 19, 1982. Regulation: 8.