ST art® 58230
ST art® 58230 is a Class II device made by Diagnostica Stago, cleared under FDA 510(k) K904297 on 13 Nov 1990 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 03607450582307), active as of 12 Nov 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 | Number03607450582307 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904297 | Date13 Nov 1990 | StatusActive |
Official records
- AccessGUDID record 03607450582307
- FDA 510(k) database K904297
Across registries
- FDA 510(k) K904297 decided 13 Nov 1990 Active
- FDA GUDID UDI-DI 03607450582307 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K904297
- Listed FDA GUDID 03607450582307
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ST art®
- Generic name
- Coagulation analyser IVD, laboratory, semi-automated
- Model / reference
- 58230
- Primary DI / UDI-DI
- 03607450582307
- 510(k) Number
- FDA product code
- GKP
- GMDN term
- Coagulation analyser IVD, laboratory, semi-automated
- Device class
- Class II
- Regulation number
- 864.5400
- GUDID distribution status
- In Commercial Distribution
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