510(k) K160712

VITROS Chemistry Products hsCRP Reagent by Ortho Clinical Diagnostics — Product Code DCK

K160712 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Chemistry Products hsCRP Reagent". The FDA issued a decision of Substantially Equivalent on July 14, 2017. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.