510(k) Report

Devices descending from K900196

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.20210—