ACE CEDIA CORTISOL ASSAY

ACE CEDIA CORTISOL ASSAY is an FDA 510(k)-cleared medical device (K943427) manufactured by Schiapparelli Biosystems, Inc.. 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 November 27, 1994. Regulation: 8.