Teg Hemostasis System 07-015
Teg Hemostasis System 07-015 is a Class II device made by Haemonetics Corporation, cleared under FDA 510(k) K041502 on 1 Sep 2004 and listed in FDA GUDID since 13 Mar 2017 (UDI-DI 10812747018067), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10812747018067 | Date13 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041502 | Date1 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 10812747018067
- FDA 510(k) database K041502
Across registries
- FDA 510(k) K041502 decided 1 Sep 2004 Active
- FDA GUDID UDI-DI 10812747018067 listed 13 Mar 2017 Listed
Recalls
-
- Terminated Z-1298-2022
When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.
Timeline
- Cleared FDA 510(k) K041502
- Listed FDA GUDID 10812747018067
- Recall initiated FDA recalls Z-1298-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Teg Hemostasis System
- Generic name
- Platelet aggregation study IVD, reagent
- Model / reference
- 07-015
- Primary DI / UDI-DI
- 10812747018067
- 510(k) Number
- FDA product code
- JOZ
- GMDN term
- Platelet aggregation study IVD, reagent
- Device class
- Class II
- Regulation number
- 864.5700
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Platelet aggregation study IVD, reagent.