ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT

ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT is an FDA 510(k)-cleared medical device (K940588) manufactured by Helix Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 1994. Regulation: 8.