
Biosite Incorporated
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TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS is an FDA 510(k)-cleared medical device (K040459) manufactured by Biosite Incorporated. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 5, 2004. Regulation: 8.