Hemosonics, LLC - FDA 510(k) Cleared Devices
Recent clearances: Quantra QStat Cartridge, QStat Cartridge, Quantra Hemostasis Analyzer
8
Total
7
Cleared
1
Denied
FDA 510(k) Regulatory Record - Hemosonics, LLC Hematology ✕
8 devices
Cleared
Aug 25, 2025
Quantra QStat Cartridge
Hematology
111d
Cleared
CT
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
Hematology
344d