ENA SCREENING CIE KIT FOR DIAGNOSTIC USE

ENA SCREENING CIE KIT FOR DIAGNOSTIC USE is an FDA 510(k)-cleared medical device (K924262) manufactured by The Binding Site, Ltd.. 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 28, 1992. Regulation: 8.