K241573
- 510(k) number
- K241573
- Device name
- Alinity m Resp-4-Plex
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-02-14
- Date received
- 2024-06-03
- 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: K241573.pdf
Official FDA record: K241573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.