510(k) K140224

EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) by Euroimmun US — Product Code LKO

K140224 is an FDA 510(k) premarket notification submitted by Euroimmun US for the device "EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)". The FDA issued a decision of Substantially Equivalent on December 9, 2014. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Euroimmun US has at least 10 other 510(k) clearances on record.