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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 BK140139
Tradename IH-Card Control
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Bio-Rad Medical Diagnostics GmbH
industriestrasse 1
dreieich,  63303, 
Regulation Number864.9650
Classification Product Code
KSF  
Date Received03/07/2014
Decision Date 10/20/2016
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 Yes
In Vitro Product No
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