K023049 is an FDA 510(k) clearance for the SYNCHRON LX I 725 CLINICAL SYSTEM. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 4, 2002, 22 days after receiving the submission on September 12, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K023049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2002 |
| Decision Date | October 04, 2002 |
| Days to Decision | 22 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 |