K250856
- 510(k) number
- K250856
- Device name
- ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
- Applicant
- Biomérieux FR
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-06-12
- Date received
- 2025-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250856.pdf
Official FDA record: K250856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.