510(k) Report

Devices descending from K230719

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251978Liaison Nes Flu a/B, RSV & Covid-19Diasorin Molecular, LLC20250—
+1K241652DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC202403