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Radiometer Medical Aps

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX2017-09-21 View
510(k) K170882 ABL90 FLEX, ABL90 FLEX PLUSMQM2017-04-28 View
510(k) K160153 ABL90 FLEX PLUSCHL2016-11-04 View
510(k) K131988 ABL90 FLEX ANALYZERCHL2013-09-17 View
510(k) K130144 ABL90 FLEXCHL2013-07-31 View
510(k) K123748 ABL90 FLEXCHL2013-05-07 View
510(k) K130415 HIGH METABOLITE QUALICHECKJJS2013-03-26 View
510(k) K130236 RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3JJS2013-03-15 View
510(k) K120326 AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGEJHX2012-11-21 View
510(k) K122729 ABL90 FLEXCHL2012-11-16 View
510(k) K122642 ABL90 FLEXCHL2012-10-26 View
510(k) K120197 ABL90 FLEXCHL2012-03-19 View
510(k) K112161 AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..KHO2012-01-20 View
510(k) K111897 ABL90CHL2011-07-19 View
510(k) K110416 ABL835 FLEX ANALYZER WITH PLEURAL PHCHL2011-03-24 View
510(k) K100777 ABL837 FLEX ANALYZERCHL2010-12-10 View
510(k) K092686 ABL90 FLEX SERIESCEM2010-08-06 View
510(k) K093154 TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMLKD2010-02-05 View
510(k) K051968 ABL8X7 FLEXCGL2006-10-16 View
510(k) K051928 AUTOCHECK6+JJY2005-10-12 View
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