510(k) K880029

EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 by Immuno-Mycologics, Inc. — Product Code KFH

K880029 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001". The FDA issued a decision of Substantially Equivalent on February 24, 1988. The device falls under product code KFH (Antiserum, Positive Control, Blastomyces Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.