Anti-HCV Next— 510(k) K252424

Name: FDA 510(k) clearance K252424
Creator: U.S. Food and Drug Administration
Published: 2026-04-28

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K252424 for Anti-HCV Next, Substantially Equivalent on 2026-04-28. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code MZO
Device class: Class 2
Regulation: 21 CFR 866.3169
Advisory panel: Microbiology
Date received: 2025-08-01
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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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.