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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 K051087
Device Name DIMENSION VISTA INTEGRATED SYSTEM
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDQ   CEM   CEP   CFQ   CFT  
CGJ   CGZ   CKA   DLZ   JGS   JHY  
JIT   JIX   JJY  
Date Received04/28/2005
Decision Date 07/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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