510(k) Report

Devices descending from K181324

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222601FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC202211
+2K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY®…Biofire Diagnostics, LLC (Biomerieux)202403