510(k) K230651

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) by Becton, Dickinson and Company — Product Code JTN

K230651 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)". The FDA issued a decision of Substantially Equivalent on June 7, 2023. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.