FDA 510(k) Applications Submitted by Radiometer Medical Aps

FDA 510(k) Number Submission Date Device Name Applicant
K131988 06/28/2013 ABL90 FLEX ANALYZER RADIOMETER MEDICAL APS
K093154 10/06/2009 TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM RADIOMETER MEDICAL APS
K112161 07/27/2011 AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. RADIOMETER MEDICAL APS
K051968 07/20/2005 ABL8X7 FLEX RADIOMETER MEDICAL APS
K043143 11/15/2004 SAFEPICO RADIOMETER MEDICAL APS
K043218 11/22/2004 ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX RADIOMETER MEDICAL APS
K041874 07/12/2004 ABL800 FLEX RADIOMETER MEDICAL APS
K051928 07/18/2005 AUTOCHECK6+ RADIOMETER MEDICAL APS
K092686 09/02/2009 ABL90 FLEX SERIES RADIOMETER MEDICAL APS
K050869 04/06/2005 MODIFICATION TO ABL800 FLEX RADIOMETER MEDICAL APS
K130144 01/22/2013 ABL90 FLEX RADIOMETER MEDICAL APS
K120197 01/23/2012 ABL90 FLEX RADIOMETER MEDICAL APS
K130236 01/30/2013 RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 RADIOMETER MEDICAL APS
K130415 02/19/2013 HIGH METABOLITE QUALICHECK RADIOMETER MEDICAL APS
K111897 07/05/2011 ABL90 RADIOMETER MEDICAL APS
K122642 08/29/2012 ABL90 FLEX RADIOMETER MEDICAL APS
K122729 09/06/2012 ABL90 FLEX RADIOMETER MEDICAL APS
K150226 02/02/2015 Hematocrit and Metabolite QUALICHECK RADIOMETER MEDICAL APS
K120326 02/02/2012 AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE RADIOMETER MEDICAL APS
K163462 12/09/2016 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical ApS
K043003 11/01/2004 TCM40 MONITORING SYSTEM RADIOMETER MEDICAL APS
K100777 03/18/2010 ABL837 FLEX ANALYZER RADIOMETER MEDICAL APS
K160153 01/22/2016 ABL90 FLEX PLUS RADIOMETER MEDICAL APS
K170882 03/24/2017 ABL90 FLEX, ABL90 FLEX PLUS Radiometer Medical ApS
K110416 02/14/2011 ABL835 FLEX ANALYZER WITH PLEURAL PH RADIOMETER MEDICAL APS
K132691 08/28/2013 ABL90 FLEX RADIOMETER MEDICAL APS
K123748 12/06/2012 ABL90 FLEX RADIOMETER MEDICAL APS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact