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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDAKOCYTOMATION EGFR PHARMDX
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
Date Received10/01/2003
Decision Date02/12/2004
Product Code
NQF[ Registered Establishments with NQF ]
Docket Number 04M-0433
Notice Date 09/24/2004
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 
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