510(k) Report

Devices descending from K001767

6 later devices reach Diamedix IS-CMV Igm Capture Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+1K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A20053—
+2K163569Elecsys CMV IgMRoche Diagnostics201702
+2K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.20170—
+2K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.20160—
+2K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.20160—