MODIFICATION OF EMIT D.A.U. OPIATES ASSAY

MODIFICATION OF EMIT D.A.U. OPIATES ASSAY is an FDA 510(k)-cleared medical device (K984232) 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 21, 1999. Regulation: 8.