510(k) K113216 ยท KHP Acid, Lactic, Enzymatic Method
RAPIDPOINT 500 BLOOD GAS ANALYER
| Applicant | Siemens Healthcare Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Nov 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2023 | Siemens Healthcare Diagnostics Inc RAPIDPOINT 500 Blood Gas System Open, Classified |
JGS | 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 19, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A
The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This s Terminated |
KHP | None listed |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Blood Gas Analyzer
Siemens Material Number (SMN):
10492730, 10696855, 10696857, 10697306 Terminated |
CHL | None listed |
| Sep 24, 2015 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests)
Part Number: 10491449
Product Usage:
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir Terminated |
KHP | None listed |
| Sep 24, 2015 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests
Part Number: 10491448
Product Usage:
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir Terminated |
KHP | None listed |
| Sep 24, 2015 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests
Part Number: 10491447
Product Usage:
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir Terminated |
KHP | None listed |
| Sep 24, 2015 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests
Part Number: 10844813
Product Usage:
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory envir Terminated |
KHP | None listed |
| Aug 28, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer,
Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306
This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin de Terminated |
KHP | None listed |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306.
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory enviro Terminated |
MQM | None listed |
| Jul 18, 2014 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Measurement Clinical Chemistry System
RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests)
Part number: 10491449;
RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests)
Part Numbe Terminated |
KHP | None listed |
| Oct 29, 2013 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 system blood gas analyzer
Product Usage:
RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This sy Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.