FDA Product Code
FDA Product Code QFR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5430
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | 2025-08-25 | Traditional | PDF ↗ |
| K240045 | QStat Cartridge | Hemosonics, LLC | 2024-03-27 | Special | PDF ↗ |
| K232215 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023-08-24 | Special | PDF ↗ |
| K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | 2023-03-24 | Special | PDF ↗ |
| K223433 | Quantra QPlus System | Hemosonics, LLC | 2022-12-13 | Special | PDF ↗ |
| K213917 | QStat Cartridge | Hemosonics, LLC | 2022-11-29 | Traditional | PDF ↗ |
| K201513 | Quantra QPlus System | Hemosonics, LLC | 2020-08-21 | Special | PDF ↗ |
| DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC | 2019-03-12 | Direct | — |
Product code QFR · Class II · Hematology. Data: openFDA.