510(k) K083844 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ADVIA CENTAUR TSH3-ULTRA METHOD
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test
Catalog Number: 06491072; Siemens Material Number: 10282378.
Intended for the invitro diagnostic use in quantitative determination of various as Terminated |
JLW | None listed |
| May 23, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test
Catalog Number: 06491080; Siemens Material Number: 10282379.
Intended for the invitro diagnostic use in quantitative determination of various a Terminated |
JLW | None listed |
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyr Terminated |
JLW | None listed |
| Sep 6, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Catalog Numbers:
2 Pa Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.