K945491 is an FDA 510(k) clearance for the SERIM(TM) BICARB PH REAGENT STRIPS, a Strip, Dialysate Ph Indicator (Class II — Special Controls, product code MNV), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on February 1, 1995, 85 days after receiving the submission on November 8, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K945491 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 1994 |
| Decision Date | February 01, 1995 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MNV — Strip, Dialysate Ph Indicator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |