510(k) K252424

Anti-HCV Next by Abbott Laboratories — Product Code MZO

K252424 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Anti-HCV Next". The FDA issued a decision of Substantially Equivalent on April 28, 2026. The device falls under product code MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus), a Class II device regulated under 21 CFR 866.3169. Abbott Laboratories has at least 10 other 510(k) clearances on record.