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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name test, hiv detection
510(k) Number BK261335
Tradenames LIAISON® diluteX, LIAISON® MUREX HIV Ab/Ag HT, LIAISON® XL
Device Name Test, HIV Detection
Original Applicant
DiaSorin Inc.
1951 northwestern avenue
stillwater,  MN  55082
Regulation Number866.3956
Classification Product Code
MZF  
Date Received03/09/2026
Decision Date 05/29/2026
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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