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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 BK120042
Tradename DailyChek QC Kit
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
American Red Cross
diagnostic manufacturing division
2025 e street nw
washington,  DC  20006
Regulation Number864.9650
Classification Product Code
KSF  
Date Received07/20/2012
Decision Date 10/06/2012
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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