510(k) K062372

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER by The Binding Site, Ltd. — Product Code DFH

K062372 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER". The FDA issued a decision of Substantially Equivalent on June 21, 2007. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.