IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT

IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT is an FDA 510(k)-cleared medical device (K800228) manufactured by Clinical Sciences, 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 February 20, 1980. Regulation: 8.