Cleared Traditional

BD BBL? Sensi-Disc? Lefamulin 20?g (LMU-20)

K230651 · Becton, Dickinson and Company · Microbiology
Jun 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K230651 is an FDA 510(k) clearance for the BD BBL? Sensi-Disc? Lefamulin 20?g (LMU-20), a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on June 7, 2023, 90 days after receiving the submission on March 9, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K230651 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2023
Decision Date June 07, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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