510(k) K070458

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 by Biomedical Diagnostics (Bmd) SA — Product Code MOB

K070458 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "MODIFICATION TO FIDIS VASCULITIS, MODEL MX007". The FDA issued a decision of Substantially Equivalent on December 21, 2007. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Biomedical Diagnostics (Bmd) SA has at least 9 other 510(k) clearances on record.