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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK170013
Tradename AlbaQ-Chek (R) Simulated Whole Blood Controls, Model Z498
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Alba Bioscience Limited
21 ellen's glen rd
edinburgh,  Midlothian,  EH17 7QT, 
Regulation Number864.9650
Classification Product Code
KSF  
Date Received02/10/2017
Decision Date 05/09/2017
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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