EZ-Chek K100-0104
EZ-Chek K100-0104 is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K101750 on 7 Jan 2011 and listed in FDA GUDID since 7 Mar 2017 (UDI-DI 00858293006151), 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 | Number00858293006151 | Date7 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101750 | Date7 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 00858293006151
- FDA 510(k) database K101750
Across registries
- FDA 510(k) K101750 decided 7 Jan 2011 Active
- FDA GUDID UDI-DI 00858293006151 listed 7 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K101750
- Listed FDA GUDID 00858293006151
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EZ-Chek
- Generic name
- Haemodialysis treatment kit
- Model / Ref / Catalog
- K100-0104
- Primary DI / UDI-DI
- 00858293006151
- 510(k) Number
- FDA product code
- MNV
- GMDN term
- Haemodialysis treatment kit
- Device class
- Class II
- Regulation number
- 876.5820
- GUDID distribution status
- In Commercial Distribution
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- RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 by Reprocessing Products Corp