EMIT-ST URINE COCAINE METABOLITE ASSAY

EMIT-ST URINE COCAINE METABOLITE ASSAY is an FDA 510(k)-cleared medical device (K820773) 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 April 7, 1982. Regulation: 8.