510(k) Report

Devices descending from K202382

6 later devices reach FilmArray Global Fever Panel External Control Kit through their predicates, nearest generation first.

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