510(k) Report

Devices descending from K961355

36 later devices reach Multicheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980135QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc.1998351
+2K150226Hematocrit and Metabolite QUALICHECKRadiometer Medical Aps20150—
+2K130415High Metabolite QualicheckRadiometer Medical Aps20130—
+2K130236Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3Radiometer Medical Aps20130—
+2K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+2K051928AUTOCHECK6+Radiometer Medical Aps20050—
+2K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc.2000314
+3K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+3K130144ABL90 FlexRadiometer Medical Aps201303
+3K122642ABL90 FlexRadiometer Medical Aps20120—
+3K120197ABL90 FlexRadiometer Medical Aps201263
+3K111897ABL90Radiometer Medical Aps201112
+3K041874ABL800 FlexRadiometer Medical Aps20042922
+4K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+4K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+4K123748ABL90 FlexRadiometer Medical Aps20130—
+4K122729ABL90 FlexRadiometer Medical Aps20125—
+4K051968ABL8X7 FlexRadiometer Medical Aps200604
+4K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+4K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+5K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+5K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+5K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+5K132691ABL90 FlexRadiometer Medical Aps20143—
+5K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—
+5K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+5K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+6K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+6K160153ABL90 Flex PlusRadiometer Medical Aps201625
+6K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+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