K253839
- 510(k) number
- K253839
- Device name
- Elecsys Anti-SARS-CoV-2
- Applicant
- Roche Diagnostics IN · US
- Product code
- QVP — Sars-Cov-2 Serology Test
- Decision date
- 2025-12-17
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253839.pdf
Official FDA record: K253839
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.