TEG5000 Hemostasis System 07-006
TEG5000 Hemostasis System 07-006 is a Class II device made by Haemonetics Corporation, cleared under FDA 510(k) K993678 on 5 May 2000 and listed in FDA GUDID since 16 Jun 2017 (UDI-DI 20812747018019), 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 | Number20812747018019 | Date16 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993678 | Date5 May 2000 | StatusActive |
Official records
- AccessGUDID record 20812747018019
- FDA 510(k) database K993678
Across registries
- FDA 510(k) K993678 decided 5 May 2000 Active
- FDA GUDID UDI-DI 20812747018019 listed 16 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K993678
- Listed FDA GUDID 20812747018019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TEG5000 Hemostasis System
- Generic name
- Multiple coagulation marker IVD, reagent
- Model / reference
- 07-006
- Primary DI / UDI-DI
- 20812747018019
- 510(k) Number
- FDA product code
- JPA
- GMDN term
- Multiple coagulation marker IVD, reagent
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution