K250956
- 510(k) number
- K250956
- Device name
- HardyDisk AST Gepotidacin 10µg (GEP10)
- Applicant
- Hardy Diagnostics CA · US
- Product code
- JTN — Susceptibility Test Discs, Antimicrobial
- Decision date
- 2025-06-26
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250956
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.