510(k) K946328

TDX(R)/TDXFLX(R) PHENYTOIN II by Abbott Laboratories — Product Code LGR

K946328 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX(R)/TDXFLX(R) PHENYTOIN II". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Abbott Laboratories has at least 10 other 510(k) clearances on record.