510(k) K073537 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
| Applicant | Siemens Medical Solutions Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, Jun 27, 2008 |
| Received | Dec 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073537
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1260 Blood Gas Analyzer
Siemens Material Number (SMN):
10321846, 10491394 Terminated |
CHL | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1265 Blood Gas Analyzer
Siemens Material Number (SMN):
10321852, 10470366, 10491395 Terminated |
CHL | None listed |
| Jul 2, 2015 | Siemens Healthcare Diagnostics, Inc The Rapidlab 1265 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 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.
The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testin Terminated |
MQM | None listed |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.
The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testin Terminated |
MQM | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDLab 1260 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 1265 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.