510(k) Report

Devices descending from K870657

48 later devices reach Avl Model 985 Electrolyte Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961458Avl 9180 Electrolyte AnalyzerAvl Scientific Corp.1996471
+2K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.20180—
+2K121040Smartlyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20120—
+2K082462Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc.20092—
+2K070104Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20081—
+2K023792Calibration Pack, Models A9100-101S and A9100-103SThermo Orion20030—
+2K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp.1997387
+3K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.20200—
+3K121140Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20120—
+3K102959Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc.20110—
+3K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+3K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+3K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc.2000314
+3K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+3K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+3K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+3K974779Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) AnalyzerAbbott Laboratories19980—
+4K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+4K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+4K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+4K051968ABL8X7 FlexRadiometer Medical Aps200604
+4K051928AUTOCHECK6+Radiometer Medical Aps20050—
+4K041874ABL800 FlexRadiometer Medical Aps20042922
+5K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+5K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+5K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+5K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+5K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+5K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+6K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+6K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+6K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+6K132691ABL90 FlexRadiometer Medical Aps20143—
+6K130144ABL90 FlexRadiometer Medical Aps201303
+6K122642ABL90 FlexRadiometer Medical Aps20120—
+6K120197ABL90 FlexRadiometer Medical Aps201263
+6K111897ABL90Radiometer Medical Aps201112
+6K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+7K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+7K160153ABL90 Flex PlusRadiometer Medical Aps201625
+7K123748ABL90 FlexRadiometer Medical Aps20130—
+7K122729ABL90 FlexRadiometer Medical Aps20125—
+7K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+8K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+8K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+8K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+8K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503
+8K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—