• 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
De Novo Number DEN160048
Device Name FilmArray NGDS Warrior Panel
Requester
BioFire Defense, LLC
79 west 4500 south, suite 14
salt lake city,  UT  84107
Contact cynthia phillips
Classification Product Code
PRD
Date Received10/17/2016
Decision Date 02/14/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
Type Direct
-
-