510(k) K002558

K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE by Kamiya Biomedical Co. — Product Code DCK

K002558 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE". The FDA issued a decision of Substantially Equivalent on October 25, 2000. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.