EMIT-STM OPIATE ASSAY

EMIT-STM OPIATE ASSAY is an FDA 510(k)-cleared medical device (K802615) 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 October 30, 1980. Regulation: 8.