510(k) K041133 ยท CDD Radioassay, Vitamin B12
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 2, 2004 |
| Received | Apr 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur T3
ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT sys Terminated |
CDP | None listed |
| May 6, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers.
This system is intended for professional use in a laboratory environ Terminated |
JJE | None listed |
| Dec 23, 2014 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur (including refurbished)
Professional use in a laboratory for in vitro diagnostic tests. Terminated |
JJE | None listed |
| Dec 23, 2014 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur XP Immunoassay System (including refurbished)
Professional use in a laboratory for in vitro diagnostic tests. Terminated |
JJE | None listed |
| Sep 29, 2014 | Siemens Healthcare Diagnostics ADVIA Centaur Immunoassay System (including refurbished units),
This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in v Terminated |
JJE | None listed |
| Sep 29, 2014 | Siemens Healthcare Diagnostics ADVIA Centaur XP Immunoassay System (including refurbished units),
This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for i Terminated |
JJE | None listed |
| Sep 18, 2014 | Siemens Healthcare Diagnostics ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, Terminated |
JJE | None listed |
| Sep 18, 2014 | Siemens Healthcare Diagnostics ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 103293 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.