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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDAKOCYTOMATION EGFR PHARMDX
Generic NameImmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
PMA NumberP030044
Date Received09/29/2003
Decision Date02/12/2004
Product Code NQF 
Docket Number 04M-0433
Notice Date 09/24/2004
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DAKOCYTOMATION EGFR PHARMDX. THE DEVICE 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 NEOPLASTIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATION. 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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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