510(k) Report

Devices descending from K980130

44 later devices reach ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System through their predicates, nearest generation first.

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