510(k) K243500

ARCHITECT iGentamicin by Abbott Laboratories — Product Code LCD

K243500 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT iGentamicin". The FDA issued a decision of Substantially Equivalent on July 9, 2025. The device falls under product code LCD (Enzyme Immunoassay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Abbott Laboratories has at least 10 other 510(k) clearances on record.