Atlas FDA

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

FDA 510(k) clearance K041133 · decided 2004-07-02

Clearance details

K-number
K041133
Device name
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Applicant
Bayer Healthcare, LLC
Decision
Substantially Equivalent
Date received
2004-04-30
Decision date
2004-07-02
Days to decision
63 days
Clearance type
Special
Product code
CDD
Device class
2
Regulation number
862.1810
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLAS recall (Z-1615-2016)Siemens Healthcare Diagnostics, Inc.2016-05-06
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagno recall (Z-0859-2015)Siemens Healthcare Diagnostics, Inc.2014-12-23
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laborato recall (Z-0860-2015)Siemens Healthcare Diagnostics, Inc.2014-12-23
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended fo recall (Z-2715-2014)Siemens Healthcare Diagnostics2014-09-29
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended recall (Z-2716-2014)Siemens Healthcare Diagnostics2014-09-29
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, recall (Z-2662-2014)Siemens Healthcare Diagnostics2014-09-18
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 102852 recall (Z-2663-2014)Siemens Healthcare Diagnostics2014-09-18

PMA approvals by this applicant

RecordFirmDate
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018)Bayer Healthcare, LLC2004-12-22
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001)Bayer Healthcare, LLC1995-12-13