BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) is an FDA 510(k)-cleared medical device (K230651) manufactured by Becton, Dickinson and Company. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2023. Regulation: 8.