EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) is an FDA 510(k)-cleared medical device (K915003) manufactured by Syva Co.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 1991. Regulation: 8.