510(k) Report

Devices descending from K122986

4 later devices reach Vidas Lyme Igg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation20181—
+1K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation20170—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504
+2K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)20260—