510(k) K140225

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO by Phadia US, Inc. — Product Code MOB

K140225 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO". The FDA issued a decision of Substantially Equivalent on October 27, 2014. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Phadia US, Inc. has at least 10 other 510(k) clearances on record.