510(k) K161721 ยท CDD Radioassay, Vitamin B12
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Sep 20, 2016 |
| Received | Jun 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161721
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.