510(k) K182747

EliA RF IgM Immunoassay by Phadia AB — Product Code DHR

K182747 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA RF IgM Immunoassay". The FDA issued a decision of Substantially Equivalent on December 18, 2018. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Phadia AB has at least 10 other 510(k) clearances on record.