510(k) K190326 ยท CDN Urease, Photometric, Urea Nitrogen
VITROS XT Chemistry Products UREA-CREA Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 14, 2019 |
| Received | Feb 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190326
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.