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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 quality control material, genetics, dna
De Novo Number DEN060007
510(K) Number K060070
Device Name INTROL CF PANEL I CONTROL
Requester
MAINE MOLECULAR QUALITY CONTROLS, INC.
10 southgate road
scarborough,  ME  04074
Contact joan gordon
Regulation Number866.5910
Classification Product Code
NZB  
Date Received08/14/2006
Decision Date 10/12/2006
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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