K083579 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 20, 2009, 78 days after receiving the submission on December 4, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K083579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2008 |
| Decision Date | February 20, 2009 |
| Days to Decision | 78 days |
| Submission Type | Abbreviated |
| 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 |