K243935
- 510(k) number
- K243935
- Device name
- Aptima CMV Quant Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay
- Decision date
- 2025-01-17
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243935.pdf
Official FDA record: K243935
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.