Medical Device Manufacturer · US , Charlottesville , VA

Hemosonics, LLC - FDA 510(k) Cleared Devices

8 submissions · 7 cleared · Since 2019

8

Total

7

Cleared

1

Denied

FDA 510(k) cleared devices by Hemosonics, LLC Hematology ✕

8 devices

1-8 of 8

Cleared Aug 25, 2025

Quantra QStat Cartridge

Hematology · 111d

Cleared Mar 27, 2024

QStat Cartridge

Hematology · 82d

Cleared Aug 24, 2023

Quantra Hemostasis Analyzer

Hematology · 29d

Cleared Mar 24, 2023

Quantra Hemostasis Analyzer

Hematology · 31d

Cleared Dec 13, 2022

Quantra QPlus System

Hematology · 29d

Cleared Nov 29, 2022

QStat Cartridge

Hematology · 349d

Cleared Aug 21, 2020

Quantra QPlus System

Hematology · 74d

Not Cleared Mar 12, 2019

Quantra Hemostasis Analyzer, QPlus Cartridge

DEN180017 · QFR

Hematology · 344d