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

510(k) Premarket Notification
  • 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 System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
510(k) Number K061686
Device Name IDI-VANR ASSAY
Applicant
Geneohm Sciences Canada, Inc.
P.O. Box 103
Baldwin,  MD  21082
Applicant Contact Judi Smith
Correspondent
Geneohm Sciences Canada, Inc.
P.O. Box 103
Baldwin,  MD  21082
Correspondent Contact Judi Smith
Regulation Number866.1640
Classification Product Code
NIJ  
Date Received06/15/2006
Decision Date 08/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-