510(k) K143118

Human Microalbumin kit for use on SPAPLUS by The Binding Site Group , Ltd. — Product Code DCF

K143118 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Human Microalbumin kit for use on SPAPLUS". The FDA issued a decision of Substantially Equivalent on May 26, 2015. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.