DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR

DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR is an FDA 510(k)-cleared medical device (K983693) 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 November 3, 1998. Regulation: 8.