SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL

SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL is an FDA 510(k)-cleared medical device (K993987) 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 26, 2000. Regulation: 8.