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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 KIT
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 NumberS009
Date Received02/25/2010
Decision Date10/07/2010
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE FORMULATION OF THE HERCEPTEST EPITOPE RETRIEVAL SOLUTION.
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