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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 K944093
Device Name DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact CAROLYN K GEORGE
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/22/1994
Decision Date 11/10/1994
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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