|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.|
|Trade Name||BOND ORACLE HER2 IHC SYSTEM|
|Classification Name||system, test, her-2/neu, ihc|
|Supplement Type||normal 180 day track|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the manufacturing changes to the bond-max software, instrument styling and usability, the reagent and bond-max instrument manufacturing processes, and associated labeling changes.