MONOHAEM (FECAL OCCULT BLOOD TEST)

MONOHAEM (FECAL OCCULT BLOOD TEST) is an FDA 510(k)-cleared medical device (K901064) manufactured by Silenus Laboratories Proprietary , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1990. Regulation: 8.