EMIT AED PHENYTOIN ASSAY

EMIT AED PHENYTOIN ASSAY is an FDA 510(k)-cleared medical device (K832033) 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 July 31, 1983. Regulation: 8.