510(k) K092587

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM by Bio-Rad Laboratories — Product Code LFX

K092587 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 3, 2010. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.