510(k) Report

Devices descending from K113846

2 later devices reach Borrelia Burgdorferi Igm Blot Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics20210—
+1K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics20210—