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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (photometric, discrete), for clinical use
510(k) Number K860021
Device Name DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact JEREMY S BRUNO
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact JEREMY S BRUNO
Regulation Number862.2160
Classification Product Code
JJE  
Date Received01/03/1986
Decision Date 02/11/1986
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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