510(k) K063866

BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM by Bio-Rad Laboratories — Product Code LIP

K063866 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 2007. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.