HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES

HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES is an FDA 510(k)-cleared medical device (K936056) manufactured by Dipro Diagnostic Products GmbH. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 1995. Regulation: 8.