CIBA CORNING ACS FOLATE ASSAY

CIBA CORNING ACS FOLATE ASSAY is an FDA 510(k)-cleared medical device (K943297) 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 December 11, 1994. Regulation: 8.