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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 system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
De Novo Number DEN050003
510(K) Number K042613
Device Name PAXGENE BLOOD RNA SYSTEM
Requester
preanalytix gmbh
1 becton drive
mc 300
franklin lakes,  NJ  07417
Contact jing zhang
Regulation Number866.4070
Classification Product Code
NTW  
Date Received02/28/2005
Decision Date 04/18/2005
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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