510(k) K191316 ยท CIX Bromcresol Green Dye-Binding, Albumin
VITROS XT Chemistry Products ALB-TP Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 7, 2019 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191316
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.