510(k) K950280

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

K950280 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX(R)/TDXFLX(R) FREE PHENYTOIN II". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code MOJ (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)), a Class II device regulated under 21 CFR 862.3350. Abbott Laboratories has at least 10 other 510(k) clearances on record.