|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.|
|Classification Name||system, test, her-2/neu, ihc|
|Generic Name||system, test, her-2/neu, ihc|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at dako denmark a/s, glostrup, denmark.