Quantra QPlus System

Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

HemoSonics, LLC

The following data is part of a premarket notification filed by Hemosonics, Llc with the FDA for Quantra Qplus System.

Pre-market Notification Details

Device IDK201513
510k NumberK201513
Device Name:Quantra QPlus System
ClassificationCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Applicant HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville,  VA  22903
ContactAnne Zavertnik
CorrespondentAnne Zavertnik
HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville,  VA  22903
Product CodeQFR  
CFR Regulation Number864.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-08-21

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