
W.H.P.M., Inc.
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HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST is an FDA 510(k)-cleared medical device (K041202) manufactured by W.H.P.M., 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 11, 2004. Regulation: 8.