K260696
- 510(k) number
- K260696
- Device name
- MTS Gepotidacin 0.016-256 µg/mL
- Applicant
- Liofilchem s.r.l. IT
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2026-04-17
- Date received
- 2026-03-03
- 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: K260696.pdf
Official FDA record: K260696
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.