PMA
P040011: C-KIT PHARMDX
FDA PMA · Immunohistochemistry antibody assay, c-kit · Dako North America, Inc.
Key facts
| PMA number | P040011 |
|---|---|
| Trade name | C-KIT PHARMDX |
| Generic name | Immunohistochemistry antibody assay, c-kit |
| Applicant | Dako North America, Inc. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | NKF |
| Approval date | Jun 27, 2005 |
| Docket number | 05M-0388 |
| Notice date | Sep 23, 2005 |
| Establishment registration | 2022180 |
| FEI number | 2022180 |
At a glance
- 1–9 Supplements
- May 16, 2017 Latest supplement decision
- Yes Withdrawn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: