510(k) Report

Devices descending from K170883

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention20251—
+1K231336T2 Biothreat PanelT2biosystems, Inc.20230—
+1K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…Biofire Defense, LLC20232—
+1K183462Applied Biosystems Bacillus anthracis Detection KitMriglobal20190—
+2K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention20260—
+2K253653Xpert Hemorrhagic FeverCepheid20261—
+3K261362Xpert Hemorrhagic FeverCepheid20260—