HARDY DISK AMPICILLIN/SULBACTAM

HARDY DISK AMPICILLIN/SULBACTAM is an FDA 510(k)-cleared medical device (K994067) 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 January 13, 2000. Regulation: 8.