510(k) K993537

K-ASSAY TRANSFERRIN by Kamiya Biomedical Co. — Product Code DDG

K993537 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY TRANSFERRIN". The FDA issued a decision of Substantially Equivalent on November 30, 1999. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.