K190326 is an FDA 510(k) clearance for the VITROS XT Chemistry Products UREA-CREA Slides. This device is classified as a Urease, Photometric, Urea Nitrogen (Class II - Special Controls, product code CDN).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 14, 2019, 29 days after receiving the submission on February 13, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K190326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2019 |
| Decision Date | March 14, 2019 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDN — Urease, Photometric, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |