K070207 is an FDA 510(k) clearance for the MULTI-ANALYTE CHEMISTRY CALIBRATOR. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 13, 2007, 81 days after receiving the submission on January 22, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K070207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2007 |
| Decision Date | April 13, 2007 |
| Days to Decision | 81 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |