Anti-HCV Next— 510(k) K262156

Name: FDA 510(k) clearance K262156
Creator: U.S. Food and Drug Administration
Published: 2026-09-23

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K262156 for Anti-HCV Next, Substantially Equivalent on 2026-09-23. Applicant: Abbott Laboratories. Device class: 2.

Summary

Anti-HCV Next from Abbott Laboratories is a hepatitis C antibody assay, filed under MZO, enzyme-linked immunosorbent assays for hepatitis C virus. The record doesn't name the analyzer platform or specimen types.

Class II, 21 CFR 866.3169. The Microbiology panel reviewed it as a Traditional 510(k).

Abbott filed from Abbott Park, Illinois. Review took 89 days (June 26 to September 23, 2026).

Clearance details

Applicant: Abbott Laboratories
Product code: Product code MZO
Device class: Class 2
Regulation: 21 CFR 866.3169
Advisory panel: Microbiology
Date received: 2026-06-26
Decision date: 2026-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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K221693 — Elecsys Anti-HCV II (08837031190)2023-01-04

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Adverse events under product code MZO

product code MZO

Malfunction: 466
Total: 466

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.