K200544 is an FDA 510(k) clearance for the SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on October 1, 2020, 212 days after receiving the submission on March 3, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K200544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | October 01, 2020 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEM - Electrode, Ion Specific, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |