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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
510(k) Number K950134
Device Name URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
Applicant
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plaza, P22-1170
Wilmington,  DE  19880 -0022
Applicant Contact CAROLYN K GEORGE
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plaza, P22-1170
Wilmington,  DE  19880 -0022
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.3250
Classification Product Code
DLN  
Date Received01/13/1995
Decision Date 03/21/1995
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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