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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 BK251272
Tradename Alba Elution Kit
Device Name Supplies, Blood-Bank
Original Applicant
Alba Bioscience Limited
5 james hamilton way
milton bridge
penicuik,  Midlothian,  EH26 0BF, 
Regulation Number864.9050
Classification Product Code
KSS  
Date Received08/28/2025
Decision Date 11/14/2025
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 Yes
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