K260770
- 510(k) number
- K260770
- Device name
- LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- Applicant
- DiaSorin, Inc. MN · US
- Product code
- LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be
- Decision date
- 2026-06-04
- Date received
- 2026-03-09
- 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: K260770.pdf
Official FDA record: K260770
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.