EMIT 700 BARBITURATE ASSAY

EMIT 700 BARBITURATE ASSAY is an FDA 510(k)-cleared medical device (K843418) 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 September 13, 1984. Regulation: 8.