510(k) Report

Devices descending from K965131

1 later device reach Borrelia Burgdorferi Igg/Igm Elisa Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981913Prevue (TM) Borrelia Burgdorferi Antibody Detection AssayChembio Diagnostic Systems, Inc.19990—