510(k) Report

Devices descending from K061008

6 later devices reach Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101918Quickvue RSV 10Quidel Corp.20104—
+1K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp.20075—
+2K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company20130—
+2K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company20122—
+3K130398Sofia (R) RSV FiaQuidel Corp.20131—
+4K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation201701