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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name coagulation system for the measurement of whole blood viscoelastic properties
De Novo Number DEN180017
Device Name Quantra Hemostasis Analyzer, QPlus Cartridge
Requester
hemosonics, llc
400 preston ave.
suite 250
charlottesville,  VA  22903
Contact anne zavertnik
Regulation Number864.5430
Classification Product Code
QFR  
Date Received04/02/2018
Decision Date 03/12/2019
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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