
Accumetrics, Inc.
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ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) is an FDA 510(k)-cleared medical device (K012701) 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 June 11, 2002. Regulation: 8.