510(k) Report

Devices descending from DEN170017

3 later devices reach FilmArray Respiratory Panel 2 plus (RP2plus) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181324FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC201823
+2K222601FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC202211
+3K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY®…Biofire Diagnostics, LLC (Biomerieux)202403