Tdm Cal TD3417
Tdm Cal TD3417 is a multiple-therapy therapeutic drug monitoring IVD (FDA Class II; FDA product code DKB, Calibrators, Drug Mixture) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K012318 on 12 Sep 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273206470), 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 | Number05055273206470 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012318 | Date12 Sep 2001 | StatusActive |
Official records
- AccessGUDID record 05055273206470
- FDA 510(k) database K012318
Across registries
- FDA 510(k) K012318 decided 12 Sep 2001 Active
- FDA GUDID UDI-DI 05055273206470 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K012318
- Listed FDA GUDID 05055273206470
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tdm Cal
- Generic name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator
- Model / Ref / Catalog
- TD3417
- Primary DI / UDI-DI
- 05055273206470
- 510(k) Number
- FDA product code
- DKB
- GMDN term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.3200
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple-therapy therapeutic drug monitoring IVD, calibrator.