EMIT IIC COCAINE METABOLITE ASSAY

EMIT IIC COCAINE METABOLITE ASSAY is an FDA 510(k)-cleared medical device (K935323) manufactured by Syva Co.. 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 February 21, 1995. Regulation: 8.