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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 NumberS005
Date Received12/08/2005
Decision Date12/30/2005
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality control steps.
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