K090338 is an FDA 510(k) clearance for the ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE, a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II — Special Controls, product code MSY), submitted by Reprocessing Products Corp (Maple Grove, US). The FDA issued a Cleared decision on May 8, 2009, 87 days after receiving the submission on February 10, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K090338 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 10, 2009 |
| Decision Date | May 08, 2009 |
| Days to Decision | 87 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 |