EMIT-ST SERUM CALBRATOR

EMIT-ST SERUM CALBRATOR is an FDA 510(k)-cleared medical device (K810464) 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 March 5, 1981. Regulation: 8.