STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI is an FDA 510(k)-cleared medical device (K033487) manufactured by Dade Behring, Inc.. 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 December 23, 2003. Regulation: 8.