K232395
- 510(k) number
- K232395
- Device name
- ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
- Applicant
- Biomérieux FR
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2023-10-05
- Date received
- 2023-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232395.pdf
Official FDA record: K232395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.