510(k) K210596

ARCHITECT Toxo IgG by Abbott Laboratories — Product Code LGD

K210596 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT Toxo IgG". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Abbott Laboratories has at least 10 other 510(k) clearances on record.