510(k) K250588

Access Rubella IgG by Beckman Coulter, Inc. — Product Code LFX

K250588 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Rubella IgG". The FDA issued a decision of Substantially Equivalent on November 17, 2025. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.