510(k) K133601 ยท CEW Radioimmunoassay, Parathyroid Hormone
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 5, 2014 |
| Received | Nov 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133601
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.