TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I

TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I is an FDA 510(k)-cleared medical device (K973126) 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 October 5, 1997. Regulation: 8.