LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is an FDA 510(k)-cleared medical device (K994110) manufactured by Diasorin/American Standard Companies. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 1999. Regulation: 8.