EMIT ST URINE ETHYL ALCOHOL ASSAY

EMIT ST URINE ETHYL ALCOHOL ASSAY is an FDA 510(k)-cleared medical device (K840171) 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 18, 1984. Regulation: 8.