510(k) K243979

Aptiva APS IgA Reagent by Inova Diagnostics, Inc. — Product Code MSV

K243979 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "Aptiva APS IgA Reagent". The FDA issued a decision of Substantially Equivalent on February 6, 2026. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.