510(k) K260770 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Mar 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260770
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.