510(k) K061138

ABX PENTRA 400 : CRP by Horiba Abx — Product Code DCK

K061138 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA 400 : CRP". The FDA issued a decision of Substantially Equivalent on September 29, 2006. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Horiba Abx has at least 10 other 510(k) clearances on record.