510(k) Report

Devices descending from K950829

5 later devices reach Mardx Lyme Disease (Igg) Marblot Strip Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163095Lyme B. burgdorferi (IgG) MarStripe TestTrinity Biotech20170—
+1K113847Borrelia Burgdorferi Igg Blot TestGold Standard Diagnostics20122—
+1K032713Boston Biomedica, Inc. Borrelia Burgdorferi Igm and IggBoston Biomedica, Inc.20030—
+2K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics20210—
+2K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics20210—