510(k) Report

Devices descending from K961828

20 later devices reach Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—
+1K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad200212—
+1K981622Dade Tru-Liquid Cardiac ControlDade Behring, Inc.19981—
+1K980556Liquichek Cardiac Markers Control LTBio-Rad199814—
+1K973974Dade Tru-Liquid Cardiac ControlDade Intl., Inc.19970—
+1K970976Cardioimmune Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc.19970—
+2K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.200411—
+2K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad200113—
+2K982591Dade Tru-Liquid Cardiac ControlDade Behring, Inc.19980—
+3K053247Validate Cardiac Marker (CM1) Calibration Verification Test SetMaine Standards Co.20060—
+3K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Bio-Rad20058—
+3K043584Liquichek BNP ControlBio-Rad Laboratories, Inc.20050—
+4K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories20150—
+4K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150—
+4K140916Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/MinipakBio-Rad Laboratories20140—
+4K123663Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories20121—
+4K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…Radiometer Medical Aps20121—
+4K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…Radiometer Medical Aps20121—
+5K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps20170—
+5K152117Dropper hsCRP High Sensitivity CRP ControlQuantimetrix Corporation20160—