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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K934144
Device Name DUPONT ACA URINE METHADONE CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plaza, P22-1158
Wilmington,  DE  19880 -0022
Applicant Contact REBECCA S AYASH
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plaza, P22-1158
Wilmington,  DE  19880 -0022
Correspondent Contact REBECCA S AYASH
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received08/25/1993
Decision Date 11/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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