
Applied Medical Devices, Inc.
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ACCU-CULT FECAL OCCULT BLOOD TEST is an FDA 510(k)-cleared medical device (K840904) manufactured by Applied Medical Devices, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 15, 1984. Regulation: 8.