510(k) Report

Devices descending from K162895

8 later devices reach Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+1K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+1K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+1K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+1K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+1K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+2K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+3K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—