Chrono-log 490
Chrono-log 490 (490-X) is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K771198 on 2 Aug 1977 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00811476010253), 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 | Number00811476010253 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k) | NumberK771198 | Date2 Aug 1977 | StatusActive |
Official records
- AccessGUDID record 00811476010253
- FDA 510(k) database K771198
Across registries
- FDA 510(k) K771198 decided 2 Aug 1977 Active
- FDA GUDID UDI-DI 00811476010253 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K771198
- Listed FDA GUDID 00811476010253
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- Withdrawn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
- 490, 490-X
- Primary DI / UDI-DI
- 00811476010253
- 510(k) Number
- FDA product code
- JBY
- 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.