510(k) K210858 ยท DLZ Enzyme Immunoassay, Phenobarbital
VITROS Chemistry Products PHBR Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 13, 2021 |
| Received | Mar 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210858
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.