510(k) Report

Devices descending from K980135

35 later devices reach QUALICHECK5+ Models S7730, S7740, S7750, S7760 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150226Hematocrit and Metabolite QUALICHECKRadiometer Medical Aps20150—
+1K130415High Metabolite QualicheckRadiometer Medical Aps20130—
+1K130236Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3Radiometer Medical Aps20130—
+1K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+1K051928AUTOCHECK6+Radiometer Medical Aps20050—
+1K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc.2000314
+2K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+2K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+2K130144ABL90 FlexRadiometer Medical Aps201303
+2K122642ABL90 FlexRadiometer Medical Aps20120—
+2K120197ABL90 FlexRadiometer Medical Aps201263
+2K111897ABL90Radiometer Medical Aps201112
+2K041874ABL800 FlexRadiometer Medical Aps20042922
+3K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+3K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+3K123748ABL90 FlexRadiometer Medical Aps20130—
+3K122729ABL90 FlexRadiometer Medical Aps20125—
+3K051968ABL8X7 FlexRadiometer Medical Aps200604
+3K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+3K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+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—
+4K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—
+4K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+4K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+5K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+5K160153ABL90 Flex PlusRadiometer Medical Aps201625
+5K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+5K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+6K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+6K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+6K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+6K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503