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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 NameDAKOCYTOMATION HERCEP TEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namedako anti-her2 ihc system
ApplicantDAKOCYTOMATION CALIFORNIA, INC.
PMA NumberP980018
Supplement NumberS002
Date Received05/14/2003
Decision Date06/11/2003
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing method for the conjugation of the two proteins to the activated dextran to one step followed by only one purification step.
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