510(k) K202067

EliA SmDP-S by Phadia AB — Product Code LKP

K202067 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA SmDP-S". The FDA issued a decision of Substantially Equivalent on July 14, 2021. The device falls under product code LKP (Anti-Sm 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.