EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY

EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY is an FDA 510(k)-cleared medical device (K897114) 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 17, 1990. Regulation: 8.