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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, equipment, automated bloodborne pathogen
510(k) Number BK140153
Tradename ADVIA Centaur XP System (SW v 7.1)
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Siemens Healthcare Diagnostics, Inc.
511 benedict ave
tarrytown,  NY  10591
Classification Product Code
MZA  
Date Received07/18/2014
Decision Date 06/08/2015
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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