510(k) K093459

ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 by Phadia US, Inc. — Product Code MST

K093459 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01". The FDA issued a decision of Substantially Equivalent on August 13, 2010. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Phadia US, Inc. has at least 10 other 510(k) clearances on record.