K060373 is an FDA 510(k) clearance for the COBAS 6000 SERIES SYSTEM. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 13, 2006, 28 days after receiving the submission on February 13, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K060373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2006 |
| Decision Date | March 13, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CEM — Electrode, Ion Specific, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |