510(k) K120056

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER by The Binding Site Group , Ltd. — Product Code DFH

K120056 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER". The FDA issued a decision of Substantially Equivalent on April 1, 2013. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.