FDA 510(k) Applications for Medical Device Product Code "QFR"

FDA 510(k) Number Applicant Device Name Decision Date
K213917 HemoSonics, LLC QStat Cartridge 11/29/2022
K230461 HemoSonics, LLC Quantra Hemostasis Analyzer 03/24/2023
K232215 HemoSonics, LLC Quantra Hemostasis Analyzer 08/24/2023
DEN180017 HemoSonics, LLC Quantra Hemostasis Analyzer, QPlus Cartridge 03/12/2019
K201513 HemoSonics, LLC Quantra QPlus System 08/21/2020
K223433 HemoSonics, LLC Quantra QPlus System 12/13/2022


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