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) | Registration & Listing | Adverse Events | Recalls | PMA | 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, tumor marker, monitoring, bladder
510(K) Number K013785
Device Name UROVYSION BLADDER CANCER RECURRENCE KIT
Applicant
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Contact russel k enns
Regulation Number866.6010
Classification Product Code
MMW  
Date Received11/14/2001
Decision Date 02/08/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-