HardyDisk AST Gepotidacin 10µg (GEP10)— 510(k) K260842
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K260842 for HardyDisk AST Gepotidacin 10µg (GEP10), Substantially Equivalent on 2026-05-11. Applicant: Hardy Diagnostics. Device class: 2.
Summary
Hardy Diagnostics' HardyDisk AST Gepotidacin 10µg (GEP10) is filed under JTN, antimicrobial susceptibility test discs.
Class II, 21 CFR 866.1620. Microbiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Hardy filed from Santa Maria, California. Review took 56 calendar days (March 16 to May 11, 2026).
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Product code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Recent devices under product code JTN
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