STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK

STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK is an FDA 510(k)-cleared medical device (K984093) 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 13, 1998. Regulation: 8.