510(k) K190520 ยท CGA Glucose Oxidase, Glucose
VITROS XT Chemistry Products GLU-Ca Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190520
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.