K241921
- 510(k) number
- K241921
- Device name
- Alinity m BKV
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- QMI — Nucleic Acid Amplification Test For The Quantitation
- Decision date
- 2025-03-24
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K241921.pdf
Official FDA record: K241921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.