• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
-
-