510(k) Report

Devices descending from K101918

4 later devices reach Quickvue RSV 10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company20130—
+1K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company20122—
+2K130398Sofia (R) RSV FiaQuidel Corp.20131—
+3K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation201701