FLUOROMATIC PHENOLBARBITAL FIA

FLUOROMATIC PHENOLBARBITAL FIA is an FDA 510(k)-cleared medical device (K800090) manufactured by Bio-Rad. 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 January 22, 1980. Regulation: 8.