K243485
- 510(k) number
- K243485
- Device name
- Alinity m CMV
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay
- Decision date
- 2025-07-01
- Date received
- 2024-11-08
- 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: K243485.pdf
Official FDA record: K243485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.