510(k) K230461
- Device
- Quantra Hemostasis Analyzer
- Applicant
- Hemosonics, LLC
- 510(k) number
- K230461
- Product code
- QFR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-24
- Date received
- 2023-02-21
- Regulation
- 864.5430
- Classification name
- Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Debbie Winegar
- Address
- 4020 Stirrup Creek Dr. Suite 105 Durham NC US 27703 27703
FDA Registration Numbers#
- 3040184668
- 3014240198
Source Documents#
Other 510(k) Records For Product Code QFR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025-08-25 |
| K240045 | QStat Cartridge | Hemosonics, LLC | 2024-03-27 |
| K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023-08-24 |
| K223433 | Quantra QPlus System | Hemosonics, LLC | 2022-12-13 |
| K213917 | QStat Cartridge | Hemosonics, LLC | 2022-11-29 |
| K201513 | Quantra QPlus System | Hemosonics, LLC | 2020-08-21 |
| DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC | 2019-03-12 |