CIBA CORNING ACS CORTISOL IMMUNOASSAY

CIBA CORNING ACS CORTISOL IMMUNOASSAY is an FDA 510(k)-cleared medical device (K945367) manufactured by Ciba Corning Diagnostics 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 May 4, 1995. Regulation: 8.