510(k) K071210

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 by Biomedical Diagnostics (Bmd) SA — Product Code LKO

K071210 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code LKO (Anti-Rnp 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.