510(k) Report

Devices descending from K180966

2 later devices reach FilmArray Pneumonia Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212727FilmArray Pneumonia PanelBiofire Diagnostics, LLC202111
+2K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY®…Biofire Diagnostics, LLC (Biomerieux)202403