510(k) K132555

HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT by The Binding Site — Product Code PCN

K132555 is an FDA 510(k) premarket notification submitted by The Binding Site for the device "HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT". The FDA issued a decision of Substantially Equivalent on December 20, 2013. 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 has at least 10 other 510(k) clearances on record.