510(k) Report

Devices descending from K181493

2 later devices reach FilmArray Blood Culture Identification (BCID) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC202017
+2K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…Biofire Diagnostics, LLC20240—