TRUE FOCUS Control Solution Level 2
TRUE FOCUS Control Solution Level 2 is a Class I device made by Trividia Health, Inc., cleared under FDA 510(k) K131013 on 17 Oct 2013 and listed in FDA GUDID since 26 Feb 2021 (UDI-DI 00021292008437), 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 | Number00021292008437 | Date26 Feb 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131013 | Date17 Oct 2013 | StatusActive |
Official records
- AccessGUDID record 00021292008437
- FDA 510(k) database K131013
Across registries
- FDA 510(k) K131013 decided 17 Oct 2013 Active
- FDA GUDID UDI-DI 00021292008437 listed 26 Feb 2021 Listed
Timeline
- Cleared FDA 510(k) K131013
- Listed FDA GUDID 00021292008437
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- True Focus
- Generic name
- Glucose IVD, control
- Model / reference
- TRUE FOCUS Control Solution Level 2
- Primary DI / UDI-DI
- 00021292008437
- 510(k) Number
- FDA product code
- JJX
- GMDN term
- Glucose IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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