PMA
P030044: DAKOCYTOMATION EGFR PHARMDX
FDA PMA · Immunohistochemistry assay, antibody, epidermal growth factor receptor · Agilent Technologies, Inc.
Key facts
| PMA number | P030044 |
|---|---|
| Trade name | DAKOCYTOMATION EGFR PHARMDX |
| Generic name | Immunohistochemistry assay, antibody, epidermal growth factor receptor |
| Applicant | Agilent Technologies, Inc. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | NQF |
| Approval date | Feb 12, 2004 |
| Docket number | 04M-0433 |
| Notice date | Sep 24, 2004 |
| Establishment registration | 2916205 |
| FEI number | 2916205 |
At a glance
- 1–9 Supplements
- Mar 13, 2019 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: