510(k) Report

Devices descending from K112177

8 later devices reach Sofia Analyzer and Influenza a+B Fia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation201731
+1K153012Sofia Influenza A+B FIAQuidel Corporation20164—
+1K123793Sofia Strep a FiaQuidel Corporation20132—
+2K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)20260—
+2K180288QuickVue Influenza A+BQuidel Corporation20181—
+2K141775Sofia (R) Strep a+ FiaQuidel Corporation201411
+3K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC20200—
+3K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation20170—