510(k) Report

Devices descending from K213954

6 later devices reach BIOFIRE SPOTFIRE Respiratory (R) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC202421
+1K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC20232—
+2K251978Liaison Nes Flu a/B, RSV & Covid-19Diasorin Molecular, LLC20250—
+2K241652DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC202403
+2K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC20241—
+3K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC20250—