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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K950181
Device Name URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
Applicant
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plz., P22-1170
Wilmington,  DE  19880
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plz., P22-1170
Wilmington,  DE  19880
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received01/17/1995
Decision Date 04/05/1995
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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