www.fdanews.com/articles/199389-becton-dickinson-earns-510k-clearance-for-flow-cytometer-and-sample-preparation-system
Becton Dickinson Earns 510(k) Clearance for Flow Cytometer and Sample-Preparation System
October 6, 2020
Becton Dickinson has received 510(k) marketing clearance from the FDA for its integrated BD FACSLyric flow cytometer and FACSDuet sample-preparation system.
The system allows clinical laboratories to fully automate the sample-to-result process, which reduces errors by limiting manual interactions when running assays on the flow cytometer.
The system, which earned a CE mark certification in March 2019, is now available in the U.S.