ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT

ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT is an FDA 510(k)-cleared medical device (K982121) manufactured by Trace Scientific , Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1998. Regulation: 8.