510(k) K101407

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 by Immuno-Mycologics, Inc. — Product Code MIZ

K101407 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102". The FDA issued a decision of Substantially Equivalent on July 19, 2011. The device falls under product code MIZ (Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum), a Class II device regulated under 21 CFR 866.3320. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.