510(k) K843286

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 by Immuno-Mycologics, Inc. — Product Code LRF

K843286 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "EI-CANDIDA ENZYME IMMUNOASSAY EI1001". The FDA issued a decision of Substantially Equivalent on October 1, 1984. The device falls under product code LRF (Candida Spp., Direct Antigen, Id), a Class II device regulated under 21 CFR 866.3165. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.