K260447
- 510(k) number
- K260447
- Device name
- ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- Applicant
- bioMérieux SA FR
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2026-04-21
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K260447.pdf
Official FDA record: K260447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.