K213486 is an FDA 510(k) clearance for the GLP systems Track. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 10, 2022, 132 days after receiving the submission on October 29, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K213486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |