K031267 is an FDA 510(k) clearance for the STERICHEK BICARB PH REAGENT STRIPS, a Strip, Dialysate Ph Indicator (Class II — Special Controls, product code MNV), submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on December 23, 2003, 246 days after receiving the submission on April 21, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K031267 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 21, 2003 |
| Decision Date | December 23, 2003 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MNV — Strip, Dialysate Ph Indicator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |