SIGMA CX-3 CALIBRATION STANDARD LEVEL 2

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 is an FDA 510(k)-cleared medical device (K933693) 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 12, 1993. Regulation: 8.