FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Quantra Hemostasis Analyzer, QPlus Cartridge
K Number: DEN180017
·
Decision Mar 12, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
6
Applicant Total
6
Review Days
344
Basic Information
- Device Name
- Quantra Hemostasis Analyzer, QPlus Cartridge
- K Number
- DEN180017
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.5430
- Medical Specialty
- Hematology
- Decision
- Unknown
- Applicant
- HemoSonics, LLC
- Date Received
- April 2, 2018
- Decision Date
- March 12, 2019
- 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 | ||
|---|---|---|---|
| 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 |
| K213917 | QStat Cartridge | Nov 29, 2022 | Substantially Equivalent |
| K201513 | Quantra QPlus System | Aug 21, 2020 | Substantially Equivalent |