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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, immunomagnetic, circulating cancer cell, enumeration
De Novo Number DEN040001
510(K) Number K031588
Device Name CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
Requester
advanced diagnostic systems
1001 us hwy 202
raritan,  NJ  08869 -0606
Contact debra j rasmussen
Regulation Number866.6020
Classification Product Code
NQI  
Date Received01/02/2004
Decision Date 01/21/2004
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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