PMA
P230016: MAGE-A4 IHC 1F9 pharmDx
FDA PMA · Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 · Agilent Technologies, Inc.
Key facts
| PMA number | P230016 |
|---|---|
| Trade name | MAGE-A4 IHC 1F9 pharmDx |
| Generic name | Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 |
| Applicant | Agilent Technologies, Inc. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | SBL |
| Approval date | Aug 1, 2024 |
| Docket number | 24M-5449 |
| Establishment registration | 2022180 |
| FEI number | 2022180 |
At a glance
- 1–9 Supplements
- Sep 21, 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- No Withdrawn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: