510(k) K993480

K-ASSAY HAPTOGLOBIN by Kamiya Biomedical Co. — Product Code DAD

K993480 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY HAPTOGLOBIN". The FDA issued a decision of Substantially Equivalent on November 24, 1999. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.