510(k) K093137

K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL by Kamiya Biomedical Co. — Product Code NDY

K093137 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL". The FDA issued a decision of Substantially Equivalent on September 28, 2010. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.