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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 test, factor v leiden mutations, genomic dna pcr
De Novo Number DEN030005
510(K) Number K033607
Device Name FACTOR V LEIDEN KIT
Requester
roche diagnostics corp.
9115 hague rd.
indianapolos,  IN  46250
Contact robert a gregg
Regulation Number864.7280
Classification Product Code
NPQ  
Date Received12/08/2003
Decision Date 12/17/2003
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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