K994226 is an FDA 510(k) clearance for the STERICHEK TOTAL CHLORINE REAGENT STRIPS. This device is classified as a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II — Special Controls, product code MSY).
Submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on March 22, 2000, 98 days after receiving the submission on December 15, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K994226 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 1999 |
| Decision Date | March 22, 2000 |
| Days to Decision | 98 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 |