510(k) K182353

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay by Phadia AB — Product Code LJM

K182353 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay". The FDA issued a decision of Substantially Equivalent on November 27, 2018. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Phadia AB has at least 10 other 510(k) clearances on record.