PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS is an FDA 510(k)-cleared medical device (K871352) manufactured by Helena Laboratories. 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 21, 1987. Regulation: 8.