AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT is an FDA 510(k)-cleared medical device (K873064) manufactured by Amtec Diagnostics International, 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 November 3, 1987. Regulation: 8.