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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
510(k) Number K881344
Device Name ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Applicant Contact KENNETH L WOODLIN
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Department
Barley Mill Plaza, P22-1170
Wilmington,  DE  19898
Correspondent Contact KENNETH L WOODLIN
Regulation Number862.3040
Classification Product Code
DIC  
Date Received03/30/1988
Decision Date 01/24/1989
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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