510(k) Report

Devices descending from K011097

3 later devices reach Quickvue Dipstick Strep a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123793Sofia Strep a FiaQuidel Corporation20132—
+2K141775Sofia (R) Strep a+ FiaQuidel Corporation201411
+3K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation20170—