K260046
- 510(k) number
- K260046
- Device name
- Elecsys Anti-HBc II
- Applicant
- Roche Diagnostics IN · US
- Product code
- SEI — Qualitative And Quantitative Hepatitis B Virus Antib
- Decision date
- 2026-04-07
- Date received
- 2026-01-07
- 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: K260046.pdf
Official FDA record: K260046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.