DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN

DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN is an FDA 510(k)-cleared medical device (K063508) 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 January 22, 2007. Regulation: 8.