• 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 CISH PHARMDX KIT
Generic Namechromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer
Applicant
DAKO DENMARK A/S
42 produktionsvej
dk-2600
glostrup DK-26-2600
PMA NumberP100024
Supplement NumberS010
Date Received07/01/2016
Decision Date09/27/2016
Product Code NYQ 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the DakoLink software version 4.1 update for the HER2 CISH pharmDx Kit
-
-