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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name trichomonas vaginalis nucleic acid amplification test system
De Novo Number DEN110012
510(K) Number K102911
Device Name APTIMA TRICHOMONAS VAGINALIS ASSAY
Requester
GEN-PROBE INCORPORATED
10210 genetic center drive
san diego,  CA  92121
Contact maria carmelita s baluyot
Regulation Number866.3860
Classification Product Code
OUY  
Date Received04/13/2011
Decision Date 04/19/2011
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type Post-NSE
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