510(k) Report

Devices descending from K212727

1 later device reach FilmArray Pneumonia Panel through their predicates, nearest generation first.

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