510(k) Report

Devices descending from K123620

18 later devices reach Filmarray Respiratory Panel (RP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183597QIAstat-Dx Respiratory PanelQIAGEN GmbH20190—
+1K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.201515
+1K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemBiofire Diagnostics, LLC201510—
+1K133673Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit…Meridian Bioscience, Inc.20145—
+2K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.20250—
+2K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation201721
+2K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc.20170—
+2K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC20160—
+2K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC201661
+2K143206AmpliVue Bordetella AssayQuidel Corporation20140—
+3K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20181—
+3K163636ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated20170—
+3K170604FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC20174—
+4K192485BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20191—
+4K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20180—
+4K172629Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20171—
+5K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20260—
+5K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20230—