Hemosonics L L C Sc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3014240198
• FEI Number: 3014240198
• Name: HemoSonics, LLC (SC)
• Owner & Operator: HemoSonics, LLC
• Contact Address: 400 Preston Avenue Suite 250; Charlottesville VA 22903 US
• Official Correspondent:
  • Anne Zavertnik
  • 1-434-2021032-100
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4020 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	Device	Date
PMN DEN180017 | QFR HemoSonics, LLC (SC) [HemoSonics, LLC]	Quantra? Quality Control Level 2	2019-04-15
PMN DEN180017 | QFR HemoSonics, LLC (SC) [HemoSonics, LLC]	Quantra? Quality Control Level 1	2019-04-15
PMN DEN180017 | QFR HemoSonics, LLC (SC) [HemoSonics, LLC]	Quantra? Hemostasis Analyzer	2019-04-15
PMN DEN180017 | QFR HemoSonics, LLC (SC) [HemoSonics, LLC]	QPlus? Cartridge	2019-04-15
JPA HemoSonics, LLC (SC) [HemoSonics, LLC]	Quantra Hemostasis Analyzer (HS-001)	2018-06-11
JPA HemoSonics, LLC (SC) [HemoSonics, LLC]	QStat Control Level 2 (KT-0038)	2018-06-11
JPA HemoSonics, LLC (SC) [HemoSonics, LLC]	QStat Control Level 1 (KT-0028)	2018-06-11
JPA HemoSonics, LLC (SC) [HemoSonics, LLC]	QStat Cartridge (KT-0022)	2018-06-11
JPA HemoSonics, LLC (SC) [HemoSonics, LLC]	QPlus Cartridge (KT-0010)	2018-06-11