K980164 is an FDA 510(k) clearance for the STERICHEK PERACETIC ACID REAGENT STRIPS, 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 April 16, 1998, 90 days after receiving the submission on January 16, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K980164 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 1998 |
| Decision Date | April 16, 1998 |
| Days to Decision | 90 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 |