510(k) K110586 ยท MRG System, Test, Vitamin D
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 14, 2011 |
| Received | Mar 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Vitamin D Total Assay
SMN 10699201 (100 test) Terminated |
MRG | None listed |
| Oct 5, 2016 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Vitamin D Total Assay
SMN SMN 10699533 (500 test) Terminated |
MRG | None listed |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra 2500 tests
Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944.
Intended for the invitro diagnostic use in quantitative determination of various assays Terminated |
JLW | None listed |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994.
Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centa Terminated |
MRG | None listed |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems VitD 500 test, Ready Pack,
Catalog Number: 10631021.
Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Cen Terminated |
MRG | None listed |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems VitD Total 100 test, Ready Pack,
For OUS; SMN 10699201.
Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA C Terminated |
MRG | None listed |
| Mar 21, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Vitamin D Diluent 2-pack,
Reference 10494100
in vitro diagnostic use in the quantitative determination of total
25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin Terminated |
MRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.