K050423 is an FDA 510(k) clearance for the OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE). This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 22, 2005, 63 days after receiving the submission on February 18, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K050423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2005 |
| Decision Date | April 22, 2005 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |