510(k) Report

Devices descending from K895292

1 later device reach Lyme Igg Elisa Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.20210—