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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 NumberS018
Date Received11/21/2013
Decision Date11/26/2013
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes made to enhance safety of herceptest. When used for gastric and gastroesophageal cancer indications.
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