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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 K130276
Device Name DIMENSION EXL WITH LM SYSTEM
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE M/S 514
P.O. BOX 6101
NEWARK,  DE  19714 -3026
Applicant Contact PAMELA A JURGA
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE M/S 514
P.O. BOX 6101
NEWARK,  DE  19714 -3026
Correspondent Contact PAMELA A JURGA
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Code
CEC  
Date Received02/05/2013
Decision Date 03/22/2013
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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