510(k) Report

Devices descending from K230404

3 later devices reach BIOFIRE FILMARRAY Gastrointestinal (GI) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC20242—
+2K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation20260—
+2K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC20250—