510(k) Report

Devices descending from K191398

1 later device reach ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia… through their predicates, nearest generation first.

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