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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHERCEPTEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
DAKO A/S
42 produktionsvej
glostrup DK-26-2600
PMA NumberP980018
Supplement NumberS018
Date Received11/21/2013
Decision Date11/26/2013
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
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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