K230651 is an FDA 510(k) clearance for the BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20). This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K230651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JTN — Susceptibility Test Discs, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1620 |