NA3851
NA3851 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K043268 on 15 Feb 2005 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273204698), 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 | Number05055273204698 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043268 | Date15 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 05055273204698
- FDA 510(k) database K043268
Across registries
- FDA 510(k) K043268 decided 15 Feb 2005 Active
- FDA GUDID UDI-DI 05055273204698 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K043268
- Listed FDA GUDID 05055273204698
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Sodium (Na+) IVD, reagent
- Model / Ref / Catalog
- NA3851
- Primary DI / UDI-DI
- 05055273204698
- 510(k) Number
- FDA product code
- CEI
- GMDN term
- Sodium (Na+) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1665
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CEI (Uranyl Acetate/Zinc Acetate, Sodium).