
New Bay Bioresearch Co. , Ltd.
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FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST is an FDA 510(k)-cleared medical device (K063693) manufactured by New Bay Bioresearch Co. , 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 May 10, 2007. Regulation: 8.