K014034 is an FDA 510(k) clearance for the MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO). This device is classified as a Ph Rate Measurement, Carbon-dioxide (Class II - Special Controls, product code JFL).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 18, 2001, 11 days after receiving the submission on December 7, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K014034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2001 |
| Decision Date | December 18, 2001 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFL — Ph Rate Measurement, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |