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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 BK180280
Tradename DG Gel Essential Control
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Medion Grifols Diagnostics AG
bonnstrasse 9
duedingen,  Switzerland,  3186, 
Regulation Number864.9650
Classification Product Code
KSF  
Date Received11/01/2018
Decision Date 01/17/2019
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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