510(k) Report

Devices descending from K240984

1 later device reach i-STAT hs-TnI cartridge with the i-STAT 1 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.20260—