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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 BK220779
Tradename Capture Positive Control Cell
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Immucor, Inc.
3130 gateway drive
norcross,  GA  30071
Regulation Number864.9650
Classification Product Code
KSF  
Secondary Product Code
KSF 
Date Received10/26/2022
Decision Date 05/10/2023
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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