HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 is an FDA 510(k)-cleared medical device (K170127) 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 March 13, 2017. Regulation: 8.