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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazo colorimetry, bilirubin
510(k) Number K862359
Device Name METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number862.1110
Classification Product Code
CIG  
Date Received06/23/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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