510(k) K210902

EliA Ro52, EliA Ro60 by Phadia AB — Product Code LKJ

K210902 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA Ro52, EliA Ro60". The FDA issued a decision of Substantially Equivalent on July 27, 2022. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Phadia AB has at least 10 other 510(k) clearances on record.