510(k) K030687

K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C by Kamiya Biomedical Co. — Product Code DAP

K030687 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C". The FDA issued a decision of Substantially Equivalent on June 27, 2003. 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.