510(k) Report

Devices descending from K193519

1 later device reach BioFire Blood Culture Identification 2 (BCID2) Panel through their predicates, nearest generation first.

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