Submission Details
| 510(k) Number | K190326 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS XT Chemistry Products UREA-CREA Slides
Mar 2019
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K190326 is an FDA 510(k) clearance for the VITROS XT Chemistry Products UREA-CREA Slides, 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 review panel. Regulated under 21 CFR 862.1770.
Device Classification
| Product Code | CDN — Urease, Photometric, Urea Nitrogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1770 |
Manufacturer
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