Atlas FDA

BAYER ADVIA 1650 CHEMISTRY SYSTEM

FDA 510(k) clearance K990346 · decided 1999-05-21

Clearance details

K-number
K990346
Device name
BAYER ADVIA 1650 CHEMISTRY SYSTEM
Applicant
Bayer Corp.
Decision
Substantially Equivalent
Date received
1999-02-04
Decision date
1999-05-21
Days to decision
106 days
Clearance type
Traditional
Product code
JGS
Device class
2
Regulation number
862.1665
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 Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analy recall (Z-0755-2016)Siemens Healthcare Diagnostics, Inc.2016-02-04
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siem recall (Z-1399-2015)Siemens Healthcare Diagnostics, Inc.2015-04-07
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA recall (Z-0940-2014)Siemens Healthcare Diagnostics, Inc.2014-02-09
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyze recall (Z-0800-2014)Siemens Healthcare Diagnostics, Inc.2014-01-21
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty recall (Z-0343-2014)Siemens Healthcare Diagnostics2013-11-18
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty recall (Z-0344-2014)Siemens Healthcare Diagnostics2013-11-18
ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-0351-2007)Bayer Healthcare, LLC (Diagnostics Division)2007-01-17
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-0352-2007)Bayer Healthcare, LLC (Diagnostics Division)2007-01-17
ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-0353-2007)Bayer Healthcare, LLC (Diagnostics Division)2007-01-17
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-1448-06)Bayer Healthcare, LLC (Diagnostics Division)2006-08-29
ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-1449-06)Bayer Healthcare, LLC (Diagnostics Division)2006-08-29
Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma a recall (Z-1450-06)Bayer Healthcare, LLC (Diagnostics Division)2006-08-29