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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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