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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 reagents for molecular diagnostic test systems
De Novo Number DEN130042
510(K) Number K133136
Device Name MISEQDX UNIVERSAL KIT 1.0
Requester
ILLUMINA, INC.
5200 illumina way
san diego,  CA  92122
Contact leanne m kiviharju
Regulation Number862.3800
Classification Product Code
PFT  
Date Received10/04/2013
Decision Date 11/19/2013
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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