510(k) Report

Devices descending from K050537

8 later devices reach Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories20150—
+1K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150—
+1K140916Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/MinipakBio-Rad Laboratories20140—
+1K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories20121—
+1K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps20121—
+1K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps20121—
+2K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps20170—
+2K152117Dropper hsCRP High Sensitivity CRP ControlQuantimetrix Corporation20160—