510(k) K191931

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) by Hardy Diagnostics — Product Code JTN

K191931 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)". The FDA issued a decision of Substantially Equivalent on July 31, 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.