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Biosite Incorporated
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TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS is an FDA 510(k)-cleared medical device (K050799) 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 June 28, 2005. Regulation: 8.