510(k) Report

Devices descending from K951709

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech20170—
+1K113846Borrelia Burgdorferi Igm Blot TestGold Standard Diagnostics20122—
+1K980351Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitBoston Biomedica, Inc.19990—
+2K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics20210—
+2K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics20210—