510(k) K863888

DU PONT PHENYTOIN ASSAY AND CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DIR

K863888 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT PHENYTOIN ASSAY AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 5, 1986. The device falls under product code DIR (Free Radical Assay, Cocaine), a Class II device regulated under 21 CFR 862.3250. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.