PHENOBARBITAL FLUORESCENT IMMUNO

PHENOBARBITAL FLUORESCENT IMMUNO is an FDA 510(k)-cleared medical device (K821408) 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 May 23, 1982. Regulation: 8.