K032287 is an FDA 510(k) clearance for the MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 18, 2003, 25 days after receiving the submission on July 24, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K032287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2003 |
| Decision Date | August 18, 2003 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |