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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 Namedakocytomation mouse anti-human egfr immunohistochemistry kit
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
PMA NumberP030044
Supplement NumberS001
Date Received11/22/2005
Decision Date02/01/2006
Product Code
NQF[ Registered Establishments with NQF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - minor
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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