510(k) K223093

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent by Inova Diagnostics, Inc. — Product Code MID

K223093 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "Aptiva APS IgG Reagent; Aptiva APS IgM Reagent". The FDA issued a decision of Substantially Equivalent on December 17, 2024. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.