510(k) Report

Devices descending from K153012

4 later devices reach Sofia Influenza A+B FIA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation201731
+2K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)20260—
+2K180288QuickVue Influenza A+BQuidel Corporation20181—
+3K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC20200—