510(k) K123021

BIOPLEX 2200 EBV IGM KIT by Bio-Rad Laboratories — Product Code LJN

K123021 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX 2200 EBV IGM KIT". The FDA issued a decision of Substantially Equivalent on November 2, 2012. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.