CHRONO-LOG vW CoFactor Software
CHRONO-LOG vW CoFactor Software is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K940792 on 13 Oct 1994 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00811476011045), active as of 22 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 | Number00811476011045 | Date21 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940792 | Date13 Oct 1994 | StatusActive |
Official records
- AccessGUDID record 00811476011045
- FDA 510(k) database K940792
Across registries
- FDA 510(k) K940792 decided 13 Oct 1994 Active
- FDA GUDID UDI-DI 00811476011045 listed 21 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K940792
- Listed FDA GUDID 00811476011045
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chrono-Log
- Generic name
- Platelet aggregation analyser IVD
- Model / reference
- vW CoFactor Software
- Primary DI / UDI-DI
- 00811476011045
- 510(k) Number
- FDA product code
- JBX, JOZ
- GMDN term
- Platelet aggregation analyser IVD
- Device class
- Class II
- Regulation number
- 864.6675, 864.5700
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Platelet aggregation analyser IVD.