HISTOPLASMA MYCELIAL ANTIGEN

HISTOPLASMA MYCELIAL ANTIGEN is an FDA 510(k)-cleared medical device (K760826) manufactured by I M, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 1976. Regulation: 8.