EMIT(R) IIC OPIATE ASSAY

EMIT(R) IIC OPIATE ASSAY is an FDA 510(k)-cleared medical device (K935117) 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 January 5, 1994. Regulation: 8.