ARCHITECT STAT TROPONIN-1; MYOGLOBIN

ARCHITECT STAT TROPONIN-1; MYOGLOBIN is an FDA 510(k)-cleared medical device (K070640) manufactured by Fisher Diagnostics. 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 September 12, 2007. Regulation: 8.