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

Premarket Approval (PMA)

  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameURO VYSION BLADDER CANCER KIT ASSAY
Classification Nametest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Generic Namefluorescence in situ hybridization(fish) reagents
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP030052
Supplement NumberS008
Date Received06/23/2011
Decision Date07/20/2011
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Implementation of an in-process validated test method for restriction enzyme digest gel electrophoresis (dna restriction analysis), change in digest restriction enzymes used in the in-process test, implementation of an in-process validated test method for dna concentration determination by uv/vis absorbance spectrophotometry, and addition of an incoming screening test for dextran sulfate.
-
-