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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, genotype, hiv drug resistance, in vitro
510(k) Number BK010024
Tradename ViroSeq HIV-1 Genotyping System
Device Name Assay, Genotype, HIV Drug Resistance, In Vitro
Original Applicant
Applied Biosystems
850 lincoln centre drive
foster city,  CA  94404
Regulation Number866.3950
Classification Product Code
NHS  
Date Received07/12/2001
Decision Date 12/10/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
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 Yes
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