K101750 is an FDA 510(k) clearance for the RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104. This device is classified as a Strip, Dialysate Ph Indicator (Class II — Special Controls, product code MNV).
Submitted by Reprocessing Products Corp (Maple Grove, US). The FDA issued a Cleared decision on January 7, 2011, 199 days after receiving the submission on June 22, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K101750 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 22, 2010 |
| Decision Date | January 07, 2011 |
| Days to Decision | 199 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 |