KAPPA IMMAGE FREELITE KIT

KAPPA IMMAGE FREELITE KIT is an FDA 510(k)-cleared medical device (K003669) 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 January 31, 2001. Regulation: 8.