HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) is an FDA 510(k)-cleared medical device (K191931) manufactured by Hardy Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2019. Regulation: 8.