Potassium (K) PT3852
Potassium (K) PT3852 is a medical device (FDA Class II; FDA product code CEJ, Tetraphenyl Borate, Colorimetry, Potassium) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K043267 on 10 Feb 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273204933), 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 | Number05055273204933 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043267 | Date10 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 05055273204933
- FDA 510(k) database K043267
Across registries
- FDA 510(k) K043267 decided 10 Feb 2005 Active
- FDA GUDID UDI-DI 05055273204933 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K043267
- Listed FDA GUDID 05055273204933
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Potassium (K)
- Generic name
- Potassium (K+) IVD, reagent
- Model / Ref / Catalog
- PT3852
- Primary DI / UDI-DI
- 05055273204933
- 510(k) Number
- FDA product code
- CEJ
- GMDN term
- Potassium (K+) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1600
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code CEJ (Tetraphenyl Borate, Colorimetry, Potassium).
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- Easy-Test Potassium K Item Number 19XXX by Em Diagnostic Systems, Inc.
- BCS POTASSIUM TURBIDIMETRIC TEST by Bioclinical Systems, Inc.