HardyDisk AST Plazomicin 30ug (PLZ30)

HardyDisk AST Plazomicin 30ug (PLZ30) is an FDA 510(k)-cleared medical device (K181700) 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 9, 2018. Regulation: 8.