MODIFIED IMIPENEM SUSCEPTIBILITY POWDER

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER is an FDA 510(k)-cleared medical device (K880574) manufactured by Merck, Sharp & Dohme. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1988. Regulation: 8.