FREELITE HUMAN KAPPA AND LAMBDA KITS

FREELITE HUMAN KAPPA AND LAMBDA KITS is an FDA 510(k)-cleared medical device (K040009) 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 March 10, 2004. Regulation: 8.