510(k) K182012 ยท JKR Radioimmunoassay, Calcitonin
ADVIA Centaur Calcitonin (CALCT) assay
| Applicant | Axis-Shield Diagnostics Limited, Dundee, GB |
| Decision | Substantially Equivalent, Dec 21, 2018 |
| Received | Jul 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182012
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.