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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 high throughput dna sequence analyzer
De Novo Number DEN130011
510(K) Number K123989
Device Name ILLUMINA MISEQDX PLATFORM
Requester
illumina, inc.
5200 illumina way
san diego,  CA  92122
Contact leanne m kiviharju
Regulation Number862.2265
Classification Product Code
PFF  
Date Received09/23/2013
Decision Date 11/19/2013
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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