K251713
- 510(k) number
- K251713
- Device name
- BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
- Applicant
- Becton, Dickinson and Company MD · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2025-08-08
- Date received
- 2025-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251713.pdf
Official FDA record: K251713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.