510(k) K253817

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La by Immunodiagnostics Systems Limited — Product Code LLL

K253817 is an FDA 510(k) premarket notification submitted by Immunodiagnostics Systems Limited for the device "IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La". The FDA issued a decision of Substantially Equivalent on August 21, 2026. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100.