Qstat Control Level 1 QStat Control Level 1 Kit (Box of 4)
Qstat Control Level 1 QStat Control Level 1 Kit (Box of 4) is a device made by Hemosonics LLC, cleared under FDA 510(k) K213917 on 29 Nov 2022 and listed in FDA GUDID since 29 Feb 2024 (UDI-DI 00850003761336), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850003761336 | Date29 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213917 | Date29 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 00850003761336
- FDA 510(k) database K213917
Across registries
- FDA 510(k) K213917 decided 29 Nov 2022 Active
- FDA GUDID UDI-DI 00850003761336 listed 29 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K213917
- Listed FDA GUDID 00850003761336
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Qstat Control Level 1
- Generic name
- Coagulation analyser IVD, laboratory
- Model / reference
- QStat Control Level 1 Kit (Box of 4)
- Primary DI / UDI-DI
- 00850003761336
- 510(k) Number
- GMDN term
- Coagulation analyser IVD, laboratory
- GUDID distribution status
- In Commercial Distribution
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