510(k) K193604

Aptiva Celiac Disease IgA Reagent by Inova Diagnostics, Inc. — Product Code MVM

K193604 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "Aptiva Celiac Disease IgA Reagent". The FDA issued a decision of Substantially Equivalent on June 16, 2021. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.