510(k) K142993

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument by Orion Diagnostica, OY — Product Code DCK

K142993 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, OY for the device "QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument". The FDA issued a decision of Substantially Equivalent on March 10, 2016. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Orion Diagnostica, OY has at least 10 other 510(k) clearances on record.