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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 BK160071
Tradename Aurora Enterprise
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
STRATEC Biomedical UK Limited
third ave, centrum 100
burton upon trent
straffordshire,  DE14 2WD, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received07/11/2016
Decision Date 10/30/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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 No
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