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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K133156
Device Name ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact PHILIP LIU
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact PHILIP LIU
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX  
Date Received10/17/2013
Decision Date 07/24/2014
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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