510(k) K151786 ยท CDD Radioassay, Vitamin B12
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Jul 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151786
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.