EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY is an FDA 510(k)-cleared medical device (K874856) 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 4, 1988. Regulation: 8.