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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameHERCEP TEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namedako anti-her2 ihc system
ApplicantDAKO CYTOMATION DENMARK A/S
PMA NumberP980018
Supplement NumberS006
Date Received05/28/2008
Decision Date02/25/2010
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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.
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