510(k) Report

Devices descending from K210958

3 later devices reach i-STAT CHEM8+ cartridge with the i-STAT 1 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231—
+1K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+2K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—