IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 is an FDA 510(k)-cleared medical device (K000012) manufactured by Diagnostic Products 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 March 2, 2000. Regulation: 8.