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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K904306
Device Name DUPONT DRUG CALIBRATOR-A
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact RICHARD M VAUGHT
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/19/1990
Decision Date 10/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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