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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 cardiac allograft gene expression profiling test system
De Novo Number DEN080007
510(K) Number K073482
Device Name ALLOMAP MOLECULAR EXPRESSION TESTING
Requester
XDX
3260 bayshore boulevard
brisbane,  CA  94005
Contact rose romeo
Regulation Number862.1163
Classification Product Code
OJQ  
Date Received08/15/2008
Decision Date 08/26/2008
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Clinical Chemistry
FDA Review Decision Summary
Type Post-NSE
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