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).
| Device | DAKOCYTOMATION EGFR PHARMDX |
| Classification Name | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor |
| Generic Name | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2003-09-29 |
| Decision Date | 2004-02-12 |
| Notice Date | 2004-09-24 |
| PMA | P030044 |
| Supplement | S |
| Product Code | NQF |
| Docket Number | 04M-0433 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030044 | | Original Filing |
| S007 |
2019-02-15 |
30-day Notice |
| S006 |
2018-12-21 |
30-day Notice |
| S005 |
2018-03-12 |
30-day Notice |
| S004 |
2017-12-26 |
30-day Notice |
| S003 |
2017-04-17 |
30-day Notice |
| S002 |
2006-04-03 |
Normal 180 Day Track |
| S001 |
2005-11-17 |
Real-time Process |
NIH GUDID Devices