510(k) K253105

HardyDisk AST Cefiderocol 30µg (FDC30) by Hardy Diagnostics — Product Code JTN

K253105 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Cefiderocol 30µg (FDC30)". The FDA issued a decision of Substantially Equivalent on November 20, 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.