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Farallon Medial, Inc.
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IMMEDIA PROTHROMBIN TIME SYSTEM is an FDA 510(k)-cleared medical device (K050243) manufactured by Farallon Medial, 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 June 5, 2005. Regulation: 8.