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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.
Classification Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Generic Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Regulation Number864.1860
6392 via real
carpinteria, CA 93013
PMA NumberP030044
Date Received09/29/2003
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002