Quantra QPlus System KT-0039
Quantra QPlus System KT-0039 is a Class II device made by Hemosonics LLC, cleared under FDA 510(k) K201513 on 21 Aug 2020, granted FDA De Novo DEN180017 on 12 Mar 2019 and listed in FDA GUDID since 11 Feb 2021 (UDI-DI 00850003761107), active as of 23 Oct 2026.
Active
510(k) De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850003761107 | Date11 Feb 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201513 | Date21 Aug 2020 | StatusActive |
| United States | FDA De NovoDENG | NumberDEN180017 | Date12 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00850003761107
- FDA 510(k) database K201513
- FDA De Novo database DEN180017
Across registries
- FDA 510(k) K201513 decided 21 Aug 2020 Active
- FDA De Novo DEN180017 decided 12 Mar 2019 Active
- FDA GUDID UDI-DI 00850003761107 listed 11 Feb 2021 Listed
Timeline
- Granted FDA De Novo DEN180017
- Cleared FDA 510(k) K201513
- Listed FDA GUDID 00850003761107
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo, FDA 510(k) Active
Specification
- Trade name
- Quantra QPlus System
- Generic name
- Coagulation analyser IVD, laboratory
- Model / Ref / Catalog
- KT-0039
- Primary DI / UDI-DI
- 00850003761107
- 510(k) Number
- De Novo Number
- FDA product code
- QFR
- GMDN term
- Coagulation analyser IVD, laboratory
- Device class
- Class II
- Regulation number
- 864.5430
- GUDID distribution status
- In Commercial Distribution