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) | 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVENTANA ALK (D5F3) CDX ASSAY
Generic NameImmunohistochemistry assay, antibody, anaplastic lymphoma kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755
PMA NumberP140025
Supplement NumberS001
Date Received08/26/2015
Decision Date09/24/2015
Product Code PKW 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
-
-