510(k) K102607

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS by Biomedical Diagnostics (Bmd) SA — Product Code LLL

K102607 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS". The FDA issued a decision of Substantially Equivalent on December 3, 2010. 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.