510(k) K031560 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
BAYER RAPIDLAB 1200 SYSTEM
| Applicant | Bayer Healthcare, LLC, Medfield MA, US |
| Decision | Substantially Equivalent, Dec 17, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393
Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, Terminated |
GKR | None listed |
| Jul 16, 2018 | Siemens Healthcare Diagnostics, Inc. RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395
Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, Terminated |
GKR | None listed |
| Apr 10, 2017 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and Terminated |
CHL | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDLab 1240 Blood Gas Analyzer
Siemens Material Number (SMN):
10321840, 10491392 Terminated |
CHL | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1245 Blood Gas Analyzer
Siemens Material Number (SMN):
10321844, 10337179, 10491393 Terminated |
CHL | None listed |
| Jul 2, 2015 | Siemens Healthcare Diagnostics, Inc The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole
blood samples. Terminated |
CGA | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDLab 1240 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitat Terminated |
CHL | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDLab 1245 system blood gas analyzer
Product Usage:
RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantita Terminated |
CHL | None listed |
| Aug 29, 2006 | Siemens Healthcare Diagnostics RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division Terminated |
CHL | None listed |
| Aug 29, 2006 | Siemens Healthcare Diagnostics RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division Terminated |
CHL | None listed |
| Mar 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys Terminated |
CHL | None listed |
| Mar 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys Terminated |
CHL | None listed |
| Mar 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy Terminated |
CHL | None listed |
| Mar 29, 2006 | Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.