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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 K110586
Device Name ADVIA CENTAUR VITAMIN D TOTAL ASSAY
Applicant
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Applicant Contact NEIL PARKER
Correspondent
Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVENUE
TARRYTOWN,  NY  10509
Correspondent Contact NEIL PARKER
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIS   JJX  
Date Received03/01/2011
Decision Date 10/14/2011
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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