510(k) Report

Devices descending from K032166

9 later devices reach Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp.20066—
+1K041445Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc.20041—
+2K101918Quickvue RSV 10Quidel Corp.20104—
+2K071101Tru RSVMeridian Bioscience, Inc.20070—
+2K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp.20075—
+3K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company20130—
+3K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company20122—
+4K130398Sofia (R) RSV FiaQuidel Corp.20131—
+5K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation201701