K254059
- 510(k) number
- K254059
- Device name
- Access anti-HBc IgM
- Applicant
- Beckman Coulter, Inc. CA · US
- Product code
- SEI — Qualitative And Quantitative Hepatitis B Virus Antib
- Decision date
- 2026-03-13
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254059.pdf
Official FDA record: K254059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.