CHRONO-LOG AGGRO/LINK8 Software
CHRONO-LOG AGGRO/LINK8 Software is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K932566 on 2 Nov 1993 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00811476011021), 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 | Number00811476011021 | Date21 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK932566 | Date2 Nov 1993 | StatusActive |
Official records
- AccessGUDID record 00811476011021
- FDA 510(k) database K932566
Across registries
- FDA 510(k) K932566 decided 2 Nov 1993 Active
- FDA GUDID UDI-DI 00811476011021 listed 21 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K932566
- Listed FDA GUDID 00811476011021
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- Withdrawn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
- AGGRO/LINK8 Software
- Primary DI / UDI-DI
- 00811476011021
- 510(k) Number
- FDA product code
- JBX
- GMDN term
- Platelet aggregation analyser IVD
- Device class
- Class II
- Regulation number
- 864.6675
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Platelet aggregation analyser IVD.