510(k) K250956

HardyDisk AST Gepotidacin 10µg (GEP10) by Hardy Diagnostics — Product Code JTN

K250956 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Gepotidacin 10µg (GEP10)". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Hardy Diagnostics has at least 10 other 510(k) clearances on record.