K053165 is an FDA 510(k) clearance for the 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 Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 14, 2005, 30 days after receiving the submission on November 14, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K053165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2005 |
| Decision Date | December 14, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |