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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 EGFR PHARMDX KIT
Classification Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Generic Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
PMA NumberP030044
Supplement NumberS001
Date Received11/17/2005
Decision Date02/01/2006
Product Code
NQF[ Registered Establishments with NQF ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional labeling changes include a clarification in the definition of positive staining for individual tumor cells, inclusion of limitation about cetuximab response rate for negative/ positive patients and performance indices for patients who had <1% positive tumor cells for egfr.
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