THYROXINE RADIOIMMUNOASSAY KIT

THYROXINE RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K801105) manufactured by Calbiochem-Behring 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 June 8, 1980. Regulation: 8.