510(k) Report

Devices descending from K021814

12 later devices reach Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+1K041192Architect Stat Troponin-I ImmunoassayFisher Diagnostics200404
+1K033155Biocentrex Cardiac PanelBiocentrex20040—
+2K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+3K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+3K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+3K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+3K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+3K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+3K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+5K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—