510(k) K243168

Alinity i Rubella IgG by Abbott Laboratories — Product Code LFX

K243168 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Alinity i Rubella IgG". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Abbott Laboratories has at least 10 other 510(k) clearances on record.