|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||dako anti-her2 ihc system|
|Applicant||DAKO CYTOMATION DENMARK A/S|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes made to enhance safety of herceptest. When used for gastric and gastroesophageal cancer indications.