Chrono-log 590
Chrono-log 590 (590-2D) is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K830749 on 16 May 1983 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00811476010369), 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 | Number00811476010369 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK830749 | Date16 May 1983 | StatusActive |
Official records
- AccessGUDID record 00811476010369
- FDA 510(k) database K830749
Across registries
- FDA 510(k) K830749 decided 16 May 1983 Active
- FDA GUDID UDI-DI 00811476010369 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K830749
- Listed FDA GUDID 00811476010369
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- Withdrawn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
- 590, 590-2D
- Primary DI / UDI-DI
- 00811476010369
- 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.