MILENIA(TM) CORTISOL (MKCO1,5)

MILENIA(TM) CORTISOL (MKCO1,5) is an FDA 510(k)-cleared medical device (K895006) manufactured by Diagnostic Products 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 October 22, 1989. Regulation: 8.