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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 BK070013
Tradename Monoclonal Control
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number864.9650
Classification Product Code
KSF  
Date Received03/20/2007
Decision Date 06/14/2007
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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