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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 K911056
Device Name DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
P.O. BOX 80022
WILMINGTON,  DE  19880
Applicant Contact RICHARD M VAUGHT
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
P.O. BOX 80022
WILMINGTON,  DE  19880
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.3350
Classification Product Code
DIP  
Date Received03/08/1991
Decision Date 04/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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