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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.
 
DeviceDAKO EGFR PHARMDX KIT
Generic Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, CA 93013
PMA NumberP030044
Supplement NumberS002
Date Received04/03/2006
Decision Date09/27/2006
Product Code NQF 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING A NEW THERAPY VECTIBIX (PANITUMUMAB) TO INTENDED USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DAKO EGFR PHARMDX KIT AND IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLATIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATIN. EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS. EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB), OR VECTIBIX (PANITUMUMAB).
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