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

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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
510(k) Number K062694
Original Applicant
louwesweg 6
amsterdam,  NL 1066 ec
Original Contact guildo brink
Regulation Number866.6040
Classification Product Code
Date Received09/11/2006
Decision Date 02/06/2007
Decision de novo petitions granted (AN)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls