CIBA CORNING ACS T4 IMMUNOASSAY

CIBA CORNING ACS T4 IMMUNOASSAY is an FDA 510(k)-cleared medical device (K905532) 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 January 14, 1991. Regulation: 8.