
Biosite Incorporated
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TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS is an FDA 510(k)-cleared medical device (K080269) manufactured by Biosite Incorporated. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2008. Regulation: 8.