GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK is an FDA 510(k)-cleared medical device (K860031) manufactured by Organon Teknika Corp.. 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 5, 1986. Regulation: 8.