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

Premarket Approval (PMA)
  • 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
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 NamePATHWAY ANTI-C-KIT PRIMARY ANTIBODY
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Namerabbit polyclonal antibody for aid in the detection of c-kit antigen in histological tissue section
Regulation Number864.1860
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP020055
Supplement NumberS001
Date Received04/16/2007
Decision Date05/16/2007
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of system operating software from dos to windows for the drop volume tester computer workstation hardware.
-
-