Medical Device Manufacturer · DK , Bronshoj

Radiometer Medical Aps

28 submissions · 28 cleared · Since 2004
28
Total
28
Cleared
0
Denied

Radiometer Medical Aps — FDA 510(k) Submissions

Radiometer Medical Aps has submitted 28 FDA 510(k) premarket notifications since 2004, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Controls For Blood-gases, (assayed And Unassayed), Bilirubin (total And Unbound) In The Neonate Test System, Monitor, Carbon-dioxide, Cutaneous, Fluorometric Method, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
K163462 · JHX Fluorometric Method, Cpk... · Chemistry
Sep 2017 286d
ABL90 FLEX, ABL90 FLEX PLUS
K170882 · MQM Bilirubin (total And... · Chemistry
Apr 2017 35d
ABL90 FLEX PLUS
K160153 · CHL Electrode Measurement,... · Chemistry
Nov 2016 287d
ABL800 FLEX with AQURE connectivity
K142898 · CHL Electrode Measurement,... · Chemistry
Jun 2015 254d
Hematocrit and Metabolite QUALICHECK
K150226 · JJS Controls For Blood-gases,... · Chemistry
May 2015 100d
ABL90 FLEX
K132691 · MQM Bilirubin (total And... · Chemistry
Nov 2014 442d
ABL90 FLEX ANALYZER
K131988 · CHL Electrode Measurement,... · Chemistry
Sep 2013 81d
ABL90 FLEX
K130144 · CHL Electrode Measurement,... · Chemistry
Jul 2013 190d
ABL90 FLEX
K123748 · CHL Electrode Measurement,... · Chemistry
May 2013 152d
HIGH METABOLITE QUALICHECK
K130415 · JJS Controls For Blood-gases,... · Chemistry
Mar 2013 35d
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · JJS Controls For Blood-gases,... · Chemistry
Mar 2013 44d
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
K120326 · JHX Fluorometric Method, Cpk... · Chemistry
Nov 2012 293d
ABL90 FLEX
K122729 · CHL Electrode Measurement,... · Chemistry
Nov 2012 71d
ABL90 FLEX
K122642 · CHL Electrode Measurement,... · Chemistry
Oct 2012 58d
ABL90 FLEX
K120197 · CHL Electrode Measurement,... · Chemistry
Mar 2012 56d
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
K112161 · KHO Fluorometer, For Clinical... · Chemistry
Jan 2012 177d
ABL90
K111897 · CHL Electrode Measurement,... · Chemistry
Jul 2011 14d
ABL835 FLEX ANALYZER WITH PLEURAL PH
K110416 · CHL Electrode Measurement,... · Chemistry
Mar 2011 38d
ABL837 FLEX ANALYZER
K100777 · CHL Electrode Measurement,... · Chemistry
Dec 2010 267d
ABL90 FLEX SERIES
K092686 · CEM Electrode, Ion Specific,... · Chemistry
Aug 2010 338d
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K093154 · LKD Monitor, Carbon-dioxide,... · Anesthesiology
Feb 2010 122d
ABL8X7 FLEX
K051968 · CGL Electrode, Ion Based,... · Chemistry
Oct 2006 453d
AUTOCHECK6+
K051928 · JJY Multi-analyte Controls,... · Chemistry
Oct 2005 86d
MODIFICATION TO ABL800 FLEX
K050869 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Aug 2005 127d
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
K043218 · CHL Electrode Measurement,... · Chemistry
May 2005 169d
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