510(k) Report

Devices descending from K160068

6 later devices reach FilmArray Respiratory Panel (RP) for use with FilmArray Torch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163636ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated20170—
+1K170604FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC20174—
+2K192485BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20191—
+2K172629Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20171—
+3K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20260—
+3K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20230—