510(k) Report

Devices descending from K081362

4 later devices reach Platelia Lyme Igm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122979Vidas Lyme IgmBiomerieux S.A.20133—
+2K173691Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation20181—
+2K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation20170—
+3K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)20260—