SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY is an FDA 510(k)-cleared medical device (K820285) 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 February 17, 1982. Regulation: 8.