510(k) K163433 ยท CGA Glucose Oxidase, Glucose
VITROS Chemistry Products GLU Slides
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Sep 18, 2017 |
| Received | Dec 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163433
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.