
The Binding Site, Ltd.
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FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER is an FDA 510(k)-cleared medical device (K051915) 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 September 5, 2005. Regulation: 8.