ClearanceBrief
510(k) K041874 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

ABL800 FLEX

ApplicantRadiometer Medical Aps, Bronshoj, DK
DecisionSubstantially Equivalent, Oct 8, 2004
ReceivedJul 12, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K041874

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Radiometer 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
CHLNone listed
Jul 24, 2024Radiometer 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
CHLNone listed
May 18, 2022Radiometer Medical ApS
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Open, Classified
CHLNone listed
May 26, 2020Radiometer 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
CHLNone listed
May 26, 2020Radiometer 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
CHLNone listed
Mar 10, 2020Radiometer 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
CHLNone listed
Mar 6, 2020Radiometer Medical ApS
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Open, Classified
CHLNone listed
Jul 3, 2018Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Terminated
CHLNone listed
Oct 24, 2017Radiometer 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
CHLNone listed
Jan 26, 2017Radiometer America Inc
The ABL800 Model#:All
Terminated
CHLNone listed
Feb 24, 2014Radiometer 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
CHLNone listed
Aug 8, 2012Radiometer 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
CHLNone listed
Aug 8, 2012Radiometer 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
CHLNone listed
Jul 15, 2009Radiometer 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
CHLNone listed
Jan 18, 2008Radiometer America Inc
ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Terminated
CHLNone listed
Oct 11, 2007Radiometer 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
CHLNone listed
Jul 24, 2007Radiometer America Inc
ABL 800 FLEX series blood gas analyzers containing software version 5.24.
Terminated
CHLNone listed
Aug 10, 2006Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.
Terminated
JFPNone listed
Aug 3, 2006Radiometer America Inc
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Terminated
CHLNone listed
Aug 3, 2006Radiometer America Inc
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.
Terminated
CHLNone listed
Aug 2, 2006Radiometer America Inc
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
Terminated
CHLNone listed
Aug 2, 2006Radiometer America Inc
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Terminated
CHLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.