510(k) Report

Devices descending from K040120

4 later devices reach Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.20240—
+1K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.20240—
+1K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…DiaSorin, Inc.20170—
+1K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.20160—