Hemosonics L L C

FDA Filings

This page includes the latest FDA filings for Hemosonics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014240198
FEI Number3014240198
NameHemoSonics, LLC (SC)
Owner & OperatorHemoSonics, LLC
Contact Address400 Preston Avenue Suite 250
Charlottesville VA 22903 US
Official Correspondent
  • Anne Zavertnik
  • 1-434-2021032-100
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4020 Stirrup Creek Suite 112 and Suite 109
Durham, NC 27703 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
HEMOSONICS, LLC
Qstat Control Level 2 2024-03-08
HEMOSONICS, LLC
Qstat Control Level 1 2024-03-08
HEMOSONICS, LLC
QStat Cartridge 2024-03-08
HEMOSONICS, LLC
Quantra QPlus System 2021-02-19
HEMOSONICS, LLC
Quantra QPlus System 2021-02-19
HEMOSONICS, LLC
Quantra QPlus System 2021-02-19
HEMOSONICS, LLC
Quantra QPlus System 2020-10-06
HemoSonics, LLC
Quantra QPlus System2020-08-21
HEMOSONICS, LLC
Qunatra QPlus System 2019-05-02
HEMOSONICS, LLC
Qunatra QPlus System 2019-05-02
HEMOSONICS, LLC
Qunatra QPlus System 2019-05-02
HEMOSONICS, LLC
Qunatra QPlus System 2019-05-02
HemoSonics, LLC (SC) [HemoSonics, LLC]
Quantra? Quality Control Level 22019-04-15
HemoSonics, LLC (SC) [HemoSonics, LLC]
Quantra? Quality Control Level 12019-04-15
HemoSonics, LLC (SC) [HemoSonics, LLC]
Quantra? Hemostasis Analyzer2019-04-15
HemoSonics, LLC (SC) [HemoSonics, LLC]
QPlus? Cartridge2019-04-15
HemoSonics, LLC
Quantra Hemostasis Analyzer, QPlus Cartridge2019-03-12
HemoSonics, LLC (SC) [HemoSonics, LLC]
Quantra Hemostasis Analyzer (HS-001)2018-06-11
HemoSonics, LLC (SC) [HemoSonics, LLC]
QStat Control Level 2 (KT-0038)2018-06-11
HemoSonics, LLC (SC) [HemoSonics, LLC]
QStat Control Level 1 (KT-0028)2018-06-11
HemoSonics, LLC (SC) [HemoSonics, LLC]
QStat Cartridge (KT-0022)2018-06-11
HemoSonics, LLC (SC) [HemoSonics, LLC]
QPlus Cartridge (KT-0010)2018-06-11

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