K042291 is an FDA 510(k) clearance for the UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 12, 2004, 80 days after receiving the submission on August 24, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K042291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2004 |
| Decision Date | November 12, 2004 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEM — Electrode, Ion Specific, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |