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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, Diphenylhydantoin
510(k) Number K843209
Device Name PHENYTOIN ACA ANALYTICAL TEST PACK
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Wilmington,  DE  19898
Applicant Contact CAROLYN L KRUER
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Wilmington,  DE  19898
Correspondent Contact CAROLYN L KRUER
Regulation Number862.3350
Classification Product Code
DIP  
Date Received08/15/1984
Decision Date 10/11/1984
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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