510(k) K121981 ยท CEW Radioimmunoassay, Parathyroid Hormone
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 21, 2013 |
| Received | Jul 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368.
For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). Terminated |
CEW | None listed |
| Jun 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361.
For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.