EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)

EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) is an FDA 510(k)-cleared medical device (K904764) 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 19, 1990. Regulation: 8.