K250344
- 510(k) number
- K250344
- Device name
- BD Phoenix Automated Microbiology System
- Applicant
- Becton, Dickinson and Company MD · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2025-03-06
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250344.pdf
Official FDA record: K250344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.