510(k) K173792

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay by Phadia AB — Product Code MOB

K173792 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay". The FDA issued a decision of Substantially Equivalent on March 13, 2018. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Phadia AB has at least 10 other 510(k) clearances on record.