510(k) K011079

K-ASSAY HS-CRP CONTROLS by Kamiya Biomedical Co. — Product Code DCK

K011079 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY HS-CRP CONTROLS". The FDA issued a decision of Substantially Equivalent on May 16, 2001. 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.