CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT is an FDA 510(k)-cleared medical device (K915235) manufactured by Incstar Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 1992. Regulation: 8.