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Hyphen Biomed
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BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 is an FDA 510(k)-cleared medical device (K043007) manufactured by Hyphen Biomed. 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 6, 2005. Regulation: 8.