510(k) Report

Devices descending from K992191

2 later devices reach Eti-EA-G Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060204Liaison EA IggDiaSorin, Inc.20061—
+2K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.20170—