510(k) Report

Devices descending from K946157

7 later devices reach Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062213Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc.200611
+1K040120Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc.20054—
+2K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.20240—
+2K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.20240—
+2K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…DiaSorin, Inc.20170—
+2K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.20160—
+2K123021Bioplex 2200 Ebv Igm KitBio-Rad Laboratories20120—