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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 BK160084
Tradename Neg Control
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
DIAGAST
parc eurasanté
251, avenue eugéne avinée
bp 9
loos cedex,  59374,  FRANCE
Regulation Number864.9650
Classification Product Code
KSF  
Date Received08/19/2016
Decision Date 02/02/2018
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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