|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|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market the herceptest kit for automated link platforms and the changes involved in the assay procedure to use the new instrument, change in the qc procedure with reference to chromogen, changes in the criteria regarding the control tissue during qc and changes in the specimen preparation.