MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER— 510(k) K041133

Clearance details

Applicant

Bayer Healthcare, LLC

Product code

Code CDD

Device class

Class 2

Regulation

21 CFR 862.1810

Advisory panel

Clinical Chemistry

Date received

2004-04-30

Decision date

2004-07-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Tarrytown, NY, US

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• Z-0720-2018 — 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 systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20170728
• Z-1615-2016 — 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 environment only. Tests performed using this system are intended for in vitro diagnostic use.Class III·Terminated·Siemens Healthcare Diagnostics, Inc.·20160330
• Z-0859-2015 — ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20141009
• Z-0860-2015 — ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20141009
• Z-2715-2014 — 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 vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.Class II·Terminated·Siemens Healthcare Diagnostics·20140819
• Z-2716-2014 — 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 in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.Class II·Terminated·Siemens Healthcare Diagnostics·20140819
• Z-2662-2014 — ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.Class II·Terminated·Siemens Healthcare Diagnostics·20140813
• Z-2663-2014 — ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.Class II·Terminated·Siemens Healthcare Diagnostics·20140813

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041133.