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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 BK210653
Tradename ORTHO Daily QC, Simulated Whole Blood Quality Control Kit (ORTHO Daily QC Kit)
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Millipore (UK) Ltd
fleming road, kirkton campus
Livingston,  EH54 7BN, 
Regulation Number864.9650
Classification Product Code
KSF  
Date Received11/29/2021
Decision Date 06/07/2022
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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