QUANTIMUNE CORTISOL RIA CORTISOL RADIO-

QUANTIMUNE CORTISOL RIA CORTISOL RADIO- is an FDA 510(k)-cleared medical device (K800045) manufactured by Bio-Rad. 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 22, 1980. Regulation: 8.