Chrono-log 591
Chrono-log 591 is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K962426 on 22 Oct 1996 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00811476010383), 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 | Number00811476010383 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962426 | Date22 Oct 1996 | StatusActive |
Official records
- AccessGUDID record 00811476010383
- FDA 510(k) database K962426
Across registries
- FDA 510(k) K962426 decided 22 Oct 1996 Active
- FDA GUDID UDI-DI 00811476010383 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K962426
- Listed FDA GUDID 00811476010383
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- Withdrawn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 / Ref / Catalog
- 591
- Primary DI / UDI-DI
- 00811476010383
- 510(k) Number
- FDA product code
- JOZ
- GMDN term
- Platelet aggregation analyser IVD
- 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 analyser IVD.