510(k) clearance

Anti-HCV Next

FDA 510(k) source

510(k) number

K262156

Applicant

Abbott Laboratories

Decision date

Sep 23, 2026

Date received

Jun 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MZO

Device type

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Device class

Class II

Regulation

21 CFR 866.3169

Advisory committee

Microbiology

Statement or summary

Summary

Third party

N

Location

Abbott Park, IL, US