CIBA CORNING ACS FOLATE IMMUNOASSAY

CIBA CORNING ACS FOLATE IMMUNOASSAY is an FDA 510(k)-cleared medical device (K921678) 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 June 8, 1992. Regulation: 8.