510(k) K102699

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS by Abbott Laboratories — Product Code LCD

K102699 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on April 1, 2011. 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.