CIBA CORNING MAGIC LITE TSH IMMUNOASSAY

CIBA CORNING MAGIC LITE TSH IMMUNOASSAY is an FDA 510(k)-cleared medical device (K862407) 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 August 28, 1986. Regulation: 8.