510(k) K213403

Aptiva CTD Essential Reagent by Inova Diagnostics, Inc. — Product Code LLL

K213403 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "Aptiva CTD Essential Reagent". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.