K252481
- 510(k) number
- K252481
- Device name
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay
- Decision date
- 2025-11-03
- Date received
- 2025-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252481.pdf
Official FDA record: K252481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.