MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL is an FDA 510(k)-cleared medical device (K813359) manufactured by American Scientific Products. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 30, 1981. Regulation: 8.