510(k) Report

Devices descending from K241194

1 later device reach BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC20250—