510(k) K091486

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR by Kamiya Biomedical Co. — Product Code DCF

K091486 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 29, 2010. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.