510(k) K161854

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS by The Binding Site Group , Ltd. — Product Code PCN

K161854 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS". The FDA issued a decision of Substantially Equivalent on October 4, 2016. The device falls under product code PCN (Immunoglobulin G Kappa Heavy And Light Chain Combined), a Class II device regulated under 21 CFR 866.5510. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.