ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT is an FDA 510(k)-cleared medical device (K951850) 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 July 17, 1995. Regulation: 8.