510(k) K932127

TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II by Abbott Laboratories — Product Code LGS

K932127 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Abbott Laboratories has at least 10 other 510(k) clearances on record.