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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cardiac allograft gene expression profiling test system
510(k) Number K073482
Device Name ALLOMAP MOLECULAR EXPRESSION TESTING
Original Applicant
XDX
3260 bayshore boulevard
brisbane,  CA  94005
Original Contact rose romeo
Regulation Number862.1163
Classification Product Code
OJQ  
Date Received12/14/2007
Decision Date 08/26/2008
Decision de novo petitions granted (AN)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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