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 |
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