510(k) Report

Devices descending from K103195

8 later devices reach I-Stat 1 Wireless Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories20175—
+1K163271i-Stat Alinity System with i-Stat Glucose testAbbott Point of Care, Inc.20170—
+1K153357i-STAT Alinity System with i-STAT Sodium testAbbott Point of Care, Inc.20160—
+2K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+3K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20213—
+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—