510(k) Report

Devices descending from K920661

4 later devices reach Vidas CMV Igg Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220949Architect CMV IgGAbbott Laboratories20220—
+1K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.20181—
+1K080008Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc.20091—
+2K120572Bioplex 2200 Torc IggBio-Rad Laboratories, Inc.20120—