K083462 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 27, 2009, 95 days after receiving the submission on November 24, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K083462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2008 |
| Decision Date | February 27, 2009 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |