
Sienco, Inc.
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SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION is an FDA 510(k)-cleared medical device (K002528) manufactured by Sienco, 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 August 30, 2000. Regulation: 8.