510(k) Report

Devices descending from DEN170047

4 later devices reach Curetis Unyvero LRT Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191967Unyvero LRT BAL ApplicationCuretis GmbH20190—
+1K180966FilmArray Pneumonia PanelBiofire Diagnostics, LLC201824
+2K212727FilmArray Pneumonia PanelBiofire Diagnostics, LLC202111
+3K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY®…Biofire Diagnostics, LLC (Biomerieux)202403