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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
510(k) Number K260770
Device Name LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact Elauteria Earnhardt
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact Elauteria Earnhardt
Classification Product Code
LOM  
Subsequent Product Code
JJF  
Date Received03/09/2026
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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