510(k) Report

Devices descending from K143005

12 later devices reach FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251868Panther Fusion GI Bacterial AssayHologic20250—
+1K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.20250—
+1K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company201811
+1K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC201696
+2K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC202333
+2K220607BD MAX Enteric Viral PanelBecton, Dickinson and Company20220—
+2K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company201721
+3K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company20250—
+3K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC20242—
+3K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company20221—
+4K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation20260—
+4K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC20250—