510(k) K113823

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT by The Binding Site Group , Ltd. — Product Code CFN

K113823 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT". The FDA issued a decision of Substantially Equivalent on March 27, 2013. The device falls under product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)), 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.