K222167 is an FDA 510(k) clearance for the E-Z Chek Chlorine Residual Test Strips (K100-0101B). This device is classified as a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II - Special Controls, product code MSY).
Submitted by Reprocessing Products Corporation (Rpc) (Tucson, US). The FDA issued a Cleared decision on October 18, 2022, 89 days after receiving the submission on July 21, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K222167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2022 |
| Decision Date | October 18, 2022 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSY - Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |