510(k) K002948

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT by Kamiya Biomedical Co. — Product Code DAP

K002948 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.