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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 avenue, suite 250
charlottesville, VA 22903
Contact
anne zavertnik
Regulation Number
864.5430
Classification Product Code
QFR
Date Received
04/02/2018
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
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