K000331 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 10, 2000, 50 days after receiving the submission on December 22, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K000331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1999 |
| Decision Date | February 10, 2000 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |