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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 assay, genotype, hiv drug resistance, in vitro
510(k) Number BK080026
Tradename ViroSeq HIV-1 Genotyping System v2.0
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 Received06/11/2008
Decision Date 07/10/2008
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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