510(k) K192326

HardyDisk AST Lefamulin 20µg (LMU20) by Hardy Diagnostics — Product Code JTN

K192326 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Lefamulin 20µg (LMU20)". The FDA issued a decision of Substantially Equivalent on September 19, 2019. 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.