Quantra Hemostasis Analyzer, QPlus Cartridge

Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

HemoSonics, LLC

The following data is part of a De Novo classification by Hemosonics, Llc with the FDA for Quantra Hemostasis Analyzer, Qplus Cartridge.

Pre-market Notification Details

DeNovo IDDEN180017
Device Name:Quantra Hemostasis Analyzer, QPlus Cartridge
ClassificationCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Applicant HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville,  VA  22903
ContactAnne Zavertnik
Product CodeQFR  
CFR Regulation Number864.5430 [🔎]
DecisionGranted (DENG)
Review Advisory BoardHematology
Classification AdvisoryHematology
TypeDirect
Date Received2018-04-02
Decision Date2019-03-12
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850003761081 DEN180017 000
10850003761074 DEN180017 000
10850003761067 DEN180017 000
00850003761039 DEN180017 000

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