K123726 is an FDA 510(k) clearance for the COBAS 8000 ISE INDIRECT NA, K, CI 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 21, 2013, 168 days after receiving the submission on December 4, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K123726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2012 |
| Decision Date | May 21, 2013 |
| Days to Decision | 168 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 |