K132418 is an FDA 510(k) clearance for the COBAS C 501 ISE INDIRECT NA, K, CL 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 December 18, 2013, 138 days after receiving the submission on August 2, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K132418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2013 |
| Decision Date | December 18, 2013 |
| Days to Decision | 138 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 |