510(k) Report

Devices descending from K191595

2 later devices reach ARCHITECT STAT High Sensitivity Troponin-I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+2K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—