ANTISMOOTH MUSCLE ANTIBODY TEST SYS

ANTISMOOTH MUSCLE ANTIBODY TEST SYS is an FDA 510(k)-cleared medical device (K810983) manufactured by Immuno-Products Industries. 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 30, 1981. Regulation: 8.