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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 K200509
Device Name ADVIA Centaur Vitamin D Total (VitD)
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10259 1
Applicant Contact Paul DaSilva
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown,  NY  10259 1
Correspondent Contact Paul DaSilva
Regulation Number862.1825
Classification Product Code
MRG  
Date Received03/02/2020
Decision Date 05/29/2020
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
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