HardyDisk AST Gepotidacin 10µg (GEP10)— 510(k) K250956
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K250956 for HardyDisk AST Gepotidacin 10µg (GEP10), Substantially Equivalent on 2025-06-26. Applicant: Hardy Diagnostics.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Code JTN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.