K250447
- 510(k) number
- K250447
- Device name
- BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
- Applicant
- Becton, Dickinson and Company MD · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2025-05-19
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K250447.pdf
Official FDA record: K250447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.