K130698 is an FDA 510(k) clearance for the DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL). 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 April 5, 2013, 22 days after receiving the submission on March 14, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K130698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2013 |
| Decision Date | April 05, 2013 |
| Days to Decision | 22 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |