510(k) K190710

EliA SymphonyS Immunoassay by Phadia AB — Product Code LLL

K190710 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA SymphonyS Immunoassay". The FDA issued a decision of Substantially Equivalent on November 29, 2019. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Phadia AB has at least 10 other 510(k) clearances on record.