510(k) Report

Devices descending from K242367

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

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