510(k) K023828

K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR by Kamiya Biomedical Co. — Product Code DCK

K023828 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR". The FDA issued a decision of Substantially Equivalent on February 4, 2003. 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.