K243489
- 510(k) number
- K243489
- Device name
- Alinity m EBV (09N43-095)
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- QLX — Nucleic Acid Amplification Test For The Quantitation
- Decision date
- 2025-07-28
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243489.pdf
Official FDA record: K243489
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.