510(k) K052439

AESKULISA GLIA A AND AESKULISA GLIA G by Aesku Diagnostics — Product Code MST

K052439 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKULISA GLIA A AND AESKULISA GLIA G". The FDA issued a decision of Substantially Equivalent on February 7, 2006. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Aesku Diagnostics has at least 8 other 510(k) clearances on record.