Approval for additional labeling changes include a clarification in the definition of positive staining for individual tumor cells, inclusion of limitation about cetuximab response rate for negative/ positive patients and performance indices for patients who had
| Device | DAKOCYTOMATION EGFR PHARMDX KIT |
| 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 | 2005-11-17 |
| Decision Date | 2006-02-01 |
| PMA | P030044 |
| Supplement | S001 |
| Product Code | NQF |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
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