510(k) Report

Devices descending from K161573

25 later devices reach FilmArray RP EZ Control Panel M265 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190222FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc.20198—
+1K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc.20177—
+1K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc.20177—
+2K202196BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc.20216—
+2K202382FilmArray Global Fever Panel External Control KitBiofire Defense, LLC20206—
+2K200010FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc.20207—
+3K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.20251—
+3K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…Biofire Defense, LLC20232—
+3K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20233—
+3K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLC20222—
+3K203680BioFire JI Control Panel M420Maine Molecular Quality Controls, Inc.20220—
+3K212576MDx-Chex for BCID2Streck, Inc.20225—
+4K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC20260—
+4K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.20260—
+4K254167MDx-Chex for BCYStreck, LLC20260—
+4K253653Xpert Hemorrhagic FeverCepheid20261—
+4K243463BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)20240—
+4K231221MDx-Chex for BC-GPStreck20231—
+4K231223MDx-Chex for BC-GNStreck20231—
+4K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…Maine Molecular Quality Controls, Inc.20232—
+5K261362Xpert Hemorrhagic FeverCepheid20260—
+5K260041MDx-Chex for BCPStreck, LLC20260—
+5K254166MDx-Chex for BCNStreck20260—
+5K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…Maine Molecular Quality Controls, Inc.20241—
+6K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.20240—