510(k) K992976

K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR by Kamiya Biomedical Co. — Product Code DDR

K992976 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 1, 1999. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.