510(k) K153730

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control by Abbott Laboratories — Product Code LIP

K153730 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control". The FDA issued a decision of Substantially Equivalent on June 15, 2016. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Abbott Laboratories has at least 10 other 510(k) clearances on record.