K251995
- 510(k) number
- K251995
- Device name
- Access anti-HAV IgM
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LOL — Hepatitis A Test (Antibody And Igm Antibody)
- Decision date
- 2026-01-27
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251995.pdf
Official FDA record: K251995
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.