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510(k) DEN180017

Quantra Hemostasis Analyzer, QPlus Cartridge by Hemosonics, LLC — Product Code QFR

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 12, 2019
Date Received
April 2, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device Class
Class II
Regulation Number
864.5430
Review Panel
HE
Submission Type

A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.

Other clearances by Hemosonics, LLC

  • K251404 — Quantra QStat Cartridge (August 25, 2025)
  • K240045 — QStat Cartridge (March 27, 2024)
  • K232215 — Quantra Hemostasis Analyzer (August 24, 2023)
  • K230461 — Quantra Hemostasis Analyzer (March 24, 2023)
  • K223433 — Quantra QPlus System (December 13, 2022)
  • K213917 — QStat Cartridge (November 29, 2022)
  • K201513 — Quantra QPlus System (August 21, 2020)

Other clearances for product code QFR

  • K251404 — Quantra QStat Cartridge (August 25, 2025)
  • K240045 — QStat Cartridge (March 27, 2024)
  • K232215 — Quantra Hemostasis Analyzer (August 24, 2023)
  • K230461 — Quantra Hemostasis Analyzer (March 24, 2023)
  • K223433 — Quantra QPlus System (December 13, 2022)
  • K213917 — QStat Cartridge (November 29, 2022)
  • K201513 — Quantra QPlus System (August 21, 2020)