K140373 is an FDA 510(k) clearance for the ISE INDIRECT NA, K, C1 FOR GEN 2. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 22, 2014, 97 days after receiving the submission on February 14, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K140373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2014 |
| Decision Date | May 22, 2014 |
| Days to Decision | 97 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 |