510(k) K113349

HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO by The Binding Site Group , Ltd. — Product Code DAE

K113349 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO". The FDA issued a decision of Substantially Equivalent on July 11, 2012. The device falls under product code DAE (Complement C9, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.