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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 BK030033
Tradename ViroSeq HIV-1 Genotyping System
Device Name Assay, Genotype, HIV Drug Resistance, In Vitro
Original Applicant
Celera Corporation
1401 harbor bay parkway
alameda,  CA  94502
Regulation Number866.3950
Classification Product Code
NHS  
Date Received06/03/2003
Decision Date 06/11/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Type 510(k) Special
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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