MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is an FDA 510(k)-cleared medical device (K001118) manufactured by DiaSorin, 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 24, 2000. Regulation: 8.