510(k) K053653

FIDIS CONNECTIVE 10, MODEL MX006 by Biomedical Diagnostics (Bmd) SA — Product Code LLL

K053653 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "FIDIS CONNECTIVE 10, MODEL MX006". The FDA issued a decision of Substantially Equivalent on March 13, 2006. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Biomedical Diagnostics (Bmd) SA has at least 9 other 510(k) clearances on record.