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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 software, blood virus applications
510(k) Number BK050035
Tradename TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System
Device Name SOFTWARE, BLOOD VIRUS APPLICATION
Original Applicant
Bayer HealthCare Diagnostics Division
p.o. box 2466
berkeley,  CA  94702 5828
Classification Product Code
MTQ  
Date Received06/14/2005
Decision Date 09/20/2005
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
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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