510(k) K113377

GLIADIN IGA AND GLIADIN LGA by Grifols USA, LLC — Product Code MST

K113377 is an FDA 510(k) premarket notification submitted by Grifols USA, LLC for the device "GLIADIN IGA AND GLIADIN LGA". The FDA issued a decision of Substantially Equivalent on December 14, 2012. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Grifols USA, LLC has at least 2 other 510(k) clearances on record.