CORTISOL RADIOIMMUNOASSAY KIT

CORTISOL RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K801203) manufactured by Technia Diagnostics , Ltd.. 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.