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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 NameHERCEPTEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namedako anti-her2 ihc system
ApplicantDAKO CYTOMATION DENMARK A/S
PMA NumberP980018
Supplement NumberS013
Date Received04/06/2011
Decision Date04/18/2011
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes that add precaution and an instruction that is intended to enhance the safe use of herceptest.
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