K250344 is an FDA 510(k) clearance for the BD Phoenix™ Automated Microbiology System. This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 6, 2025, 28 days after receiving the submission on February 6, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K250344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2025 |
| Decision Date | March 06, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1645 |