510(k) K193504

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

K193504 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Cefiderocol 30ug (FDC30)". The FDA issued a decision of Substantially Equivalent on January 23, 2020. 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.