K071801 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on July 20, 2007, 18 days after receiving the submission on July 2, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K071801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2007 |
| Decision Date | July 20, 2007 |
| Days to Decision | 18 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 |