510(k) Report

Devices descending from K163522

7 later devices reach FilmArray Warrior Control Panel M290 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202382FilmArray Global Fever Panel External Control KitBiofire Defense, LLC20206—
+2K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…Biofire Defense, LLC20232—
+2K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLC20222—
+3K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC20260—
+3K253653Xpert Hemorrhagic FeverCepheid20261—
+3K243463BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)20240—
+4K261362Xpert Hemorrhagic FeverCepheid20260—