Radiometer Medical Aps is one of 44 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
Radiometer Medical Aps - FDA 510(k) Cleared Devices
Recent clearances: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX, ABL90 FLEX, ABL90 FLEX PLUS, ABL90 FLEX PLUS
28
Total
28
Cleared
0
Denied
Radiometer Medical Aps has 28 FDA 510(k) cleared chemistry devices. Based in Bronshoj, DK.
Historical record: 28 cleared submissions from 2004 to 2017.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Radiometer Medical Aps
28 devices
Cleared
Sep 21, 2017
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
Chemistry
286d
Cleared
Apr 28, 2017
ABL90 FLEX, ABL90 FLEX PLUS
Chemistry
35d
Cleared
Nov 04, 2016
ABL90 FLEX PLUS
Chemistry
287d
Cleared
Jun 17, 2015
ABL800 FLEX with AQURE connectivity
Chemistry
254d
Cleared
May 13, 2015
Hematocrit and Metabolite QUALICHECK
Chemistry
100d
Cleared
Nov 13, 2014
ABL90 FLEX
Chemistry
442d
Cleared
Sep 17, 2013
ABL90 FLEX ANALYZER
Chemistry
81d
Cleared
Jul 31, 2013
ABL90 FLEX
Chemistry
190d
Cleared
May 07, 2013
ABL90 FLEX
Chemistry
152d
Cleared
Mar 26, 2013
HIGH METABOLITE QUALICHECK
Chemistry
35d
Cleared
Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK...
Chemistry
44d
Cleared
Nov 21, 2012
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX...
Chemistry
293d