MODIFICATION OF EMIT AND AMIKACIN ASSAY

MODIFICATION OF EMIT AND AMIKACIN ASSAY is an FDA 510(k)-cleared medical device (K833546) 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 December 7, 1983. Regulation: 8.