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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK170162
Tradename Procleix Xpress® System (Software v3.0)
Device Name Blood Establishment Computer Software and Accessories
Regulation Number864.9165
Classification Product Code
MMH  
Date Received12/21/2017
Decision Date 01/18/2018
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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