OPTIGEN ALLERGEN SPECIFIC IGE ASSAY

OPTIGEN ALLERGEN SPECIFIC IGE ASSAY is an FDA 510(k)-cleared medical device (K051677) manufactured by Hitachi Chemical Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2006. Regulation: 8.