INNOFLUOR PHENOBARBITAL

INNOFLUOR PHENOBARBITAL is an FDA 510(k)-cleared medical device (K841707) manufactured by Innotron Diagnostics. 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 22, 1984. Regulation: 8.