Anti-HCV Next— 510(k) K252424
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K252424 for Anti-HCV Next, Substantially Equivalent on 2026-04-28. Applicant: Abbott Laboratories. Device class: 2.
Summary
Abbott Laboratories' Anti-HCV Next is filed under product code MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus).
Class II, 21 CFR 866.3169. It came in as a Traditional 510(k), and Microbiology is both the classification panel and the review panel.
Abbott Laboratories filed from Abbott Park, Illinois. Review took 270 calendar days (August 1, 2025 to April 28, 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Recent devices under product code MZO
view allMore clearances from Abbott Laboratories
view allAdverse events under product code MZO
product code MZO- Malfunction
- 466
- Total
- 466
Source: openFDA MAUDE database, through . 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.