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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 BK241061
Tradename bexWISE API
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
IT Synergistics, LLC
115 tree street
flowood,  MS  39232
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/25/2024
Decision Date 10/25/2024
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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