510(k) K132082

AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK by Aesku Diagnostics — Product Code MST

K132082 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK". The FDA issued a decision of Substantially Equivalent on December 5, 2013. 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.