510(k) Report

Devices descending from K143080

10 later devices reach FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC20160—
+1K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC201661
+1K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.201515
+2K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.20250—
+2K163636ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated20170—
+2K170604FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC20174—
+3K192485BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20191—
+3K172629Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20171—
+4K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20260—
+4K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20230—