EZ-Chek K100-0106
EZ-Chek K100-0106 is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K090338 on 8 May 2009 and listed in FDA GUDID since 19 Jan 2017 (UDI-DI 00858293006090), 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 | Number00858293006090 | Date19 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090338 | Date8 May 2009 | StatusActive |
Official records
- AccessGUDID record 00858293006090
- FDA 510(k) database K090338
Across registries
- FDA 510(k) K090338 decided 8 May 2009 Active
- FDA GUDID UDI-DI 00858293006090 listed 19 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K090338
- Listed FDA GUDID 00858293006090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EZ-Chek
- Generic name
- Haemodialysis equipment residual chlorine test strip
- Model / Ref / Catalog
- K100-0106
- Primary DI / UDI-DI
- 00858293006090
- 510(k) Number
- FDA product code
- MSY
- GMDN term
- Haemodialysis equipment residual chlorine test strip
- Device class
- Class II
- Regulation number
- 876.5665
- GUDID distribution status
- In Commercial Distribution
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