510(k) Report

Devices descending from K170604

4 later devices reach FilmArray Respiratory Panel 2 (RP2) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192485BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20191—
+1K172629Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20171—
+2K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.20260—
+2K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.20230—