510(k) Report

Devices descending from K113397

1 later device reach Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin, Inc.20200—