ARCHITECT STAT TROPONIN-I IMMUNOASSAY

ARCHITECT STAT TROPONIN-I IMMUNOASSAY is an FDA 510(k)-cleared medical device (K041192) 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 August 11, 2004. Regulation: 8.