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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 K112999
Device Name DIMENSION CLINICAL CHEMISTRY SYSTEM
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
P.O. BOX 6101
MIALSTOP 514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
P.O. BOX 6101
MIALSTOP 514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CEM   CEW   CFR   CGZ   CIT  
JGS  
Date Received10/07/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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