K191496 is an FDA 510(k) clearance for the TDS Standard Solution. This device is classified as a Solution-test Standard-conductivity, Dialysis (Class II - Special Controls, product code FKH).
Submitted by Mesa Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on August 5, 2019, 61 days after receiving the submission on June 5, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K191496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2019 |
| Decision Date | August 05, 2019 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKH - Solution-test Standard-conductivity, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |