510(k) K262113

HardyDisk AST Tebipenem 10µg (TBP10) by Hardy Diagnostics — Product Code JTN

K262113 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Tebipenem 10µg (TBP10)". The FDA issued a decision of Substantially Equivalent on August 20, 2026. 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.