510(k) K990346 ยท JGS Electrode, Ion Specific, Sodium
BAYER ADVIA 1650 CHEMISTRY SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, May 21, 1999 |
| Received | Feb 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2021 | Siemens Healthcare Diagnostics, Inc. The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in rand Terminated |
JGS | None listed |
| Feb 4, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538
Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a t Terminated |
JJE | None listed |
| Aug 28, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034.
An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random Terminated |
JGS | None listed |
| Apr 7, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD.
The ADVIA XPT Chemistry System is an automated, clinical chemistry analyz Terminated |
JGS | None listed |
| Feb 9, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400
Product Usage:
The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throug Terminated |
JJE | None listed |
| Jan 21, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems.
Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Terminated |
JJE | None listed |
| Nov 18, 2013 | Siemens Healthcare Diagnostics ADVIA 1200 System Software: 1) V2.00, 2) V2.01.
Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring Terminated |
JGS | None listed |
| Nov 18, 2013 | Siemens Healthcare Diagnostics ADVIA 1650 System Software: 1) V4.01, 2) V3.52.
Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring Terminated |
JGS | None listed |
| Jan 17, 2007 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio Terminated |
LEG | None listed |
| Jan 17, 2007 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correct Terminated |
LEG | None listed |
| Jan 17, 2007 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio Terminated |
LEG | None listed |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | None listed |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | None listed |
| Aug 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.