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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K133728
Device Name DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Applicant Contact LAURA J DUGGAN, PH.D.
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact LAURA J DUGGAN, PH.D.
Regulation Number862.1225
Classification Product Code
CGX  
Date Received12/06/2013
Decision Date 01/24/2014
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
Predetermined Change
Control Plan Authorized		 No
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