SIGMA CX-3 CALIBRATION STANDARD LEVEL 1

SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 is an FDA 510(k)-cleared medical device (K933702) manufactured by Sigma Chemical Co.. 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 October 7, 1993. Regulation: 8.