510(k) K110736 ยท DBF Ferritin, Antigen, Antiserum, Control
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Mar 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number:
03439230 (2 pack) Terminated |
DBF | None listed |
| Oct 24, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number: 06567787 (6 pack) Terminated |
DBF | None listed |
| Oct 24, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)
Catalog Number: 672182005 (US Reference 6 pack) Terminated |
DBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.