K253687
- 510(k) number
- K253687
- Device name
- Access anti-HBc Total
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- SEI — Qualitative And Quantitative Hepatitis B Virus Antib
- Decision date
- 2026-02-19
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253687.pdf
Official FDA record: K253687
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.