Thermo Scientific 1245250
Thermo Scientific 1245250 is a Class II device made by Fisher Diagnostics, cleared under FDA 510(k) K955300 on 20 Dec 1995 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00845275001068), active as of 23 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 | Number00845275001068 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK955300 | Date20 Dec 1995 | StatusActive |
Official records
- AccessGUDID record 00845275001068
- FDA 510(k) database K955300
Across registries
- FDA 510(k) K955300 decided 20 Dec 1995 Active
- FDA GUDID UDI-DI 00845275001068 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K955300
- Listed FDA GUDID 00845275001068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thermo Scientific
- Generic name
- Total bilirubin IVD, kit, spectrophotometry
- Model / reference
- 1245250
- Primary DI / UDI-DI
- 00845275001068
- 510(k) Number
- FDA product code
- CIG
- GMDN term
- Total bilirubin IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1110
- GUDID distribution status
- In Commercial Distribution
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