510(k) Report

Devices descending from K232954

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC20241—
+2K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC20250—