
Biosite Incorporated
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TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL is an FDA 510(k)-cleared medical device (K974461) 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 December 9, 1997. Regulation: 8.