MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION

MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION is an FDA 510(k)-cleared medical device (K944562) manufactured by Microgenics Corp.. 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 November 1, 1994. Regulation: 8.