510(k) Report

Devices descending from K220870

2 later devices reach BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC20260—
+1K243463BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)20240—