K252102
- 510(k) number
- K252102
- Device name
- Alinity m HCV
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- MZP — Assay, Hybridization And/Or Nucleic Acid Amplificati
- Decision date
- 2025-09-25
- Date received
- 2025-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252102.pdf
Official FDA record: K252102
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.