K172232 is an FDA 510(k) clearance for the LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Ams Diagnostics (Weston, US). The FDA issued a Cleared decision on June 12, 2019, 687 days after receiving the submission on July 25, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K172232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2017 |
| Decision Date | June 12, 2019 |
| Days to Decision | 687 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JGS - Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |