STRATUS PHENOBARBITAL FLUOROMETRIC ENZ

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ is an FDA 510(k)-cleared medical device (K830701) manufactured by American Dade. 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 12, 1983. Regulation: 8.