510(k) K260770

Device

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

Applicant

DiaSorin, Inc.

510(k) number

K260770

Product code

LOM

Decision

Substantially Equivalent (SESE)

Decision date

2026-06-04

Date received

2026-03-09

Regulation

866.3172

Classification name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N