510(k) Report

Devices descending from K915892

6 later devices reach CMV Igg Elisa Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K955360Incstar Cytomegalovirus Igg Fast Elisa AssayIncstar Corp.19960—
+1K955361Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp.19964—
+2K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A20053—
+3K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.20170—
+3K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.20160—
+3K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.20160—