Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
De Novo Number DEN070009
510(K) Number K062694
Device Name MAMMAPRINT
Requester
agendia bv
louwesweg 6
amsterdam,  NL 1066 ec
Contact guildo brink
Regulation Number866.6040
Classification Product Code
NYI  
Date Received01/30/2007
Decision Date 02/06/2007
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
-
-