510(k) K041874 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL800 FLEX
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Oct 8, 2004 |
| Received | Jul 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Radiometer Medical ApS The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point Open, Classified |
CHL | None listed |
| Jul 24, 2024 | Radiometer Medical ApS ABL800 FLEX
Model Numbers 393-800 and 393-801
The ABL800 FLEX analyzers are intended for:
" In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, Open, Classified |
CHL | None listed |
| May 18, 2022 | Radiometer Medical ApS ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 Open, Classified |
CHL | None listed |
| May 26, 2020 | Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, Terminated |
CHL | None listed |
| May 26, 2020 | Radiometer Medical ApS Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all Terminated |
CHL | None listed |
| Mar 10, 2020 | Radiometer Medical ApS ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (c Terminated |
CHL | None listed |
| Mar 6, 2020 | Radiometer Medical ApS ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Open, Classified |
CHL | None listed |
| Jul 3, 2018 | Radiometer America Inc ABL800 analyzer, model numbers 393-800 and 393-801. Terminated |
CHL | None listed |
| Oct 24, 2017 | Radiometer America Inc ABL800 analyzer with FLEXQ module.
Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters Terminated |
CHL | None listed |
| Jan 26, 2017 | Radiometer America Inc The ABL800 Model#:All Terminated |
CHL | None listed |
| Feb 24, 2014 | Radiometer America Inc pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH.
An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in w Terminated |
CHL | None listed |
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, cCl, cGlu, c Terminated |
CHL | None listed |
| Aug 8, 2012 | Radiometer America Inc The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of:
-Samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, c Terminated |
CHL | None listed |
| Jul 15, 2009 | Radiometer America Inc Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.
The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. Terminated |
CHL | None listed |
| Jan 18, 2008 | Radiometer America Inc ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) Terminated |
CHL | None listed |
| Oct 11, 2007 | Radiometer America Inc Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers. Terminated |
CHL | None listed |
| Jul 24, 2007 | Radiometer America Inc ABL 800 FLEX series blood gas analyzers containing software version 5.24. Terminated |
CHL | None listed |
| Aug 10, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005. Terminated |
JFP | None listed |
| Aug 3, 2006 | Radiometer America Inc ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. Terminated |
CHL | None listed |
| Aug 3, 2006 | Radiometer America Inc Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box. Terminated |
CHL | None listed |
| Aug 2, 2006 | Radiometer America Inc Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series. Terminated |
CHL | None listed |
| Aug 2, 2006 | Radiometer America Inc D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.