510(k) Report

Devices descending from K001387

18 later devices reach I-Stat Portable Clinical Analyzer, Model 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.20121—
+1K103195I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc.20118—
+1K093297Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc.201021
+1K092849Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerEpocal, Inc.20101—
+1K090109Blood Gas, Electrolyte and Metabolite Test CardEpocal, Inc.200903
+1K061597Epoc Blood Analysis SystemEpocal, Inc.200672
+2K200107epoc Blood Analysis SystemEpocal, Inc.2020019
+2K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+2K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20205—
+2K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories20175—
+2K163271i-Stat Alinity System with i-Stat Glucose testAbbott Point of Care, Inc.20170—
+2K153357i-STAT Alinity System with i-STAT Sodium testAbbott Point of Care, Inc.20160—
+3K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+3K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20213—
+3K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+4K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231—
+4K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+5K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—