510(k) Report

Devices descending from K173691

1 later device reach Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)20260—