CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY

CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY is an FDA 510(k)-cleared medical device (K896592) manufactured by Ciba Corning Diagnostics Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 1989. Regulation: 8.