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510(k) K201513

Device
Quantra QPlus System
Applicant
HemoSonics, LLC
510(k) number
K201513
Product code
QFR  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-21
Date received
2020-06-08
Regulation
864.5430
Classification name
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anne Zavertnik
Address
400 Preston Ave. Suite 250 Charlottesville VA US 22903 22903

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QFR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251404Quantra QStat CartridgeHemosonics, LLC2025-08-25
K240045QStat CartridgeHemosonics, LLC2024-03-27
K232215Quantra Hemostasis AnalyzerHemosonics, LLC2023-08-24
K230461Quantra Hemostasis AnalyzerHemosonics, LLC2023-03-24
K223433Quantra QPlus SystemHemosonics, LLC2022-12-13
K213917QStat CartridgeHemosonics, LLC2022-11-29
DEN180017Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC2019-03-12

Legacy Summary#

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FDA Review#

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