PMA
P210026: Ki-67 IHC pharmDx
FDA PMA · Immunohistochemistry assay, antibody, Ki-67 · Agilent Technologies, Inc.
Key facts
| PMA number | P210026 |
|---|---|
| Trade name | Ki-67 IHC pharmDx |
| Generic name | Immunohistochemistry assay, antibody, Ki-67 |
| Applicant | Agilent Technologies, Inc. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | QQT |
| Approval date | Oct 12, 2021 |
| Establishment registration | 2916205 |
| FEI number | 2916205 |
At a glance
- 1–9 Supplements
- Sep 11, 2026 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- No Withdrawn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: