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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK261315
Tradename ELUclear elution kit
Device Name Supplies, Blood-Bank
Original Applicant
Hemo Bioscience Inc.
4022 stirrup creek drive
suite 311
durham,  NC  27703
Regulation Number864.9050
Classification Product Code
KSS  
Date Received01/13/2026
Decision Date 05/29/2026
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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