HISTOPLASMA CAPSULATUM, ANTIGEN YEAST

HISTOPLASMA CAPSULATUM, ANTIGEN YEAST is an FDA 510(k)-cleared medical device (K792704) manufactured by Meridian Diagnostics, 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 January 16, 1980. Regulation: 8.