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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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