510(k) K181700

HardyDisk AST Plazomicin 30ug (PLZ30) by Hardy Diagnostics — Product Code JTN

K181700 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Plazomicin 30ug (PLZ30)". The FDA issued a decision of Substantially Equivalent on July 10, 2018. 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.