510(k) K933716

ABBOTT CHAGAS ANTIBODY EIA by Abbott Laboratories — Product Code MIU

K933716 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT CHAGAS ANTIBODY EIA". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Abbott Laboratories has at least 10 other 510(k) clearances on record.