K132344 is an FDA 510(k) clearance for the E-Z CHECK OZONE TEST STRIPS. 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 February 25, 2014, 211 days after receiving the submission on July 29, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K132344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2013 |
| Decision Date | February 25, 2014 |
| Days to Decision | 211 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 |