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Accumetrics, Inc.
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ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) is an FDA 510(k)-cleared medical device (K011337) manufactured by Accumetrics, 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 October 15, 2001. Regulation: 8.