510(k) K181556

EliA M2 Immunoassay by Phadia AB — Product Code DBM

K181556 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA M2 Immunoassay". The FDA issued a decision of Substantially Equivalent on July 13, 2018. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Phadia AB has at least 10 other 510(k) clearances on record.