510(k) Report

Devices descending from K952621

46 later devices reach EML105 Electrolyte Metabolite Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962334EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc.1996451
+2K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc.1998445
+3K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+3K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+3K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc.2000314
+3K991417Abl 735 AnalyzerRadiometer America, Inc.1999162
+4K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503
+4K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO2010125
+4K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+4K051928AUTOCHECK6+Radiometer Medical Aps20050—
+4K041874ABL800 FlexRadiometer Medical Aps20042922
+4K040174Bilirubin Assay on the Omni S AnalyzerRoche Diagnostics Corp.20040—
+5K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+5K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO20162—
+5K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+5K112995Gem Premier 4000Instrumentation Laboratory CO201211—
+5K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+5K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+5K051968ABL8X7 FlexRadiometer Medical Aps200604
+5K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+5K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+6K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+6K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+6K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+6K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+6K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+6K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+6K132691ABL90 FlexRadiometer Medical Aps20143—
+6K133407Gem Premier 4000Instrumentation Laboratory CO201410—
+6K130144ABL90 FlexRadiometer Medical Aps201303
+6K122642ABL90 FlexRadiometer Medical Aps20120—
+6K120197ABL90 FlexRadiometer Medical Aps201263
+6K111897ABL90Radiometer Medical Aps201112
+7K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+7K183549GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+7K183546GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+7K173403GEM Premier 5000Instrumentation Laboratory CO20172—
+7K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO20162—
+7K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO201601
+7K160153ABL90 Flex PlusRadiometer Medical Aps201625
+7K123748ABL90 FlexRadiometer Medical Aps20130—
+7K122729ABL90 FlexRadiometer Medical Aps20125—
+8K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+8K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+8K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+8K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—