PHENYTOIN FLUORESCENT IMMUNOASSAY

PHENYTOIN FLUORESCENT IMMUNOASSAY is an FDA 510(k)-cleared medical device (K813538) manufactured by American Diagnostic Corp.. 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 December 30, 1981. Regulation: 8.