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.
 
DeviceHER2 FISH PHARMADX KIT
Generic Namesystem, test, her-2/neu, nucleic acid or serum
Applicant
Dako Denmark ApS
42 produktionsvej
2600 glostrup DK-26-2600
PMA NumberP040005
Supplement NumberS009
Date Received08/24/2012
Decision Date02/22/2013
Product Code MVD 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.
-
-