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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 BK020005
Tradename Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System
Device Name Assay, Genotype, HIV Drug Resistance, In Vitro
Original Applicant
Visible Genetics, Inc.
700 bay street, suite 1000
toronto,  Ontario M5G 1Z6, 
Regulation Number866.3950
Classification Product Code
NHS  
Date Received02/06/2002
Decision Date 04/24/2002
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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