510(k) Report

Devices descending from K201778

1 later device reach i-STAT TBI Plasma cartridge with the i-STAT Alinity System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point of Care20240—