FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QStat Cartridge
K Number: K213917
·
Decision Nov 29, 2022
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
8
Review Days
349
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Basic Information
- Device Name
- QStat Cartridge
- K Number
- K213917
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5430
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hemosonics, LLC
- Date Received
- December 15, 2021
- Decision Date
- November 29, 2022
- Product Code
- QFR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFR | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties | FDA class 2 | Hematology |
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Other Clearances by Hemosonics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K251404 | Quantra QStat Cartridge | Aug 25, 2025 | Substantially Equivalent |
| K240045 | QStat Cartridge | Mar 27, 2024 | Substantially Equivalent |
| K232215 | Quantra Hemostasis Analyzer | Aug 24, 2023 | Substantially Equivalent |
| K230461 | Quantra Hemostasis Analyzer | Mar 24, 2023 | Substantially Equivalent |
| K223433 | Quantra QPlus System | Dec 13, 2022 | Substantially Equivalent |
| K201513 | Quantra QPlus System | Aug 21, 2020 | Substantially Equivalent |
| DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Mar 12, 2019 | Unknown |