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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 calprotectin, fecal
De Novo Number DEN060001
510(K) Number K050007
Device Name PHICAL TEST
Requester
genova diagnostics
63 zillicoa st.
asheville,  NC  28801 -1074
Contact patrick hanaway
Regulation Number866.5180
Classification Product Code
NXO  
Date Received03/23/2006
Decision Date 04/26/2006
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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