510(k) Report

Devices descending from K961458

47 later devices reach Avl 9180 Electrolyte Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.20180—
+1K121040Smartlyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20120—
+1K082462Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc.20092—
+1K070104Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20081—
+1K023792Calibration Pack, Models A9100-101S and A9100-103SThermo Orion20030—
+1K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp.1997387
+2K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.20200—
+2K121140Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20120—
+2K102959Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20110—
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+2K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+2K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc.2000314
+2K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+2K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+2K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+2K974779Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) AnalyzerAbbott Laboratories19980—
+3K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+3K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+3K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+3K051968ABL8X7 FlexRadiometer Medical Aps200604
+3K051928AUTOCHECK6+Radiometer Medical Aps20050—
+3K041874ABL800 FlexRadiometer Medical Aps20042922
+4K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+4K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+4K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+4K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+4K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+4K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+5K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+5K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+5K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+5K132691ABL90 FlexRadiometer Medical Aps20143—
+5K130144ABL90 FlexRadiometer Medical Aps201303
+5K122642ABL90 FlexRadiometer Medical Aps20120—
+5K120197ABL90 FlexRadiometer Medical Aps201263
+5K111897ABL90Radiometer Medical Aps201112
+5K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+6K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+6K160153ABL90 Flex PlusRadiometer Medical Aps201625
+6K123748ABL90 FlexRadiometer Medical Aps20130—
+6K122729ABL90 FlexRadiometer Medical Aps20125—
+6K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+7K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+7K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+7K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+7K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503
+7K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—