K252424
- 510(k) number
- K252424
- Device name
- Anti-HCV Next
- Applicant
- Abbott Laboratories IL · US
- Product code
- MZO — Assay, Enzyme Linked Immunosorbent, Hepatitis C Viru
- Decision date
- 2026-04-28
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252424.pdf
Official FDA record: K252424
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.