DRUGS OF ABUSE CALIBRATOR

Calibrators, Drug Mixture

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Drugs Of Abuse Calibrator.

Pre-market Notification Details

Device IDK950139
510k NumberK950139
Device Name:DRUGS OF ABUSE CALIBRATOR
ClassificationCalibrators, Drug Mixture
Applicant E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19880 -0022
ContactCarolyn K George
CorrespondentCarolyn K George
E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19880 -0022
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-13
Decision Date1995-02-22

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