510(k) K161982

C-Reactive Protein Kit for use on SPAPLUS by The Binding Site Group — Product Code DCN

K161982 is an FDA 510(k) premarket notification submitted by The Binding Site Group for the device "C-Reactive Protein Kit for use on SPAPLUS". The FDA issued a decision of Substantially Equivalent on April 5, 2017. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. The Binding Site Group has at least 10 other 510(k) clearances on record.