RenalCheck PX PX20501
RenalCheck PX PX20501 is a Class II device made by Ibt Scientific LLC, cleared under FDA 510(k) K953854 on 11 Mar 1996 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI G212PX20501), active as of 8 Nov 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 | NumberG212PX20501 | Date6 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK953854 | Date11 Mar 1996 | StatusActive |
Official records
- FDA 510(k) database K953854
Across registries
- FDA 510(k) K953854 decided 11 Mar 1996 Active
- FDA GUDID UDI-DI G212PX20501 listed 6 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K953854
- Listed FDA GUDID G212PX20501
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RenalCheck PX
- Generic name
- Hydrogen peroxide device disinfectant/sterilant test strip
- Model / reference
- PX20501
- Primary DI / UDI-DI
- G212PX20501
- 510(k) Number
- FDA product code
- FKP
- GMDN term
- Hydrogen peroxide device disinfectant/sterilant test strip
- Device class
- Class II
- Regulation number
- 876.5820
- GUDID distribution status
- In Commercial Distribution
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