EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY

EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY is an FDA 510(k)-cleared medical device (K850712) 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 March 19, 1985. Regulation: 8.