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 kit, test, olfactory
De Novo Number DEN050007
510(K) Number K051653
Device Name HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
Requester
fmg innovations, inc.
one financial center
boston,  MA  02111
Contact linda d bentley
Regulation Number874.1600
Classification Product Code
NRK  
Date Received06/20/2005
Decision Date 03/27/2006
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Reclassification Order Reclassification Order
Type Post-NSE
-
-