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Biosite Incorporated
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TRIAGE D-DIMER TEST, MODEL 98100 is an FDA 510(k)-cleared medical device (K042890) manufactured by Biosite Incorporated. 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 28, 2004. Regulation: 8.