510(k) K950139

DRUGS OF ABUSE CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DKB

K950139 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DRUGS OF ABUSE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on February 22, 1995. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.