PMA
P150027: PD-L1 IHC 28-8 pharmDx
FDA PMA · Immunohistochemistry assay, antibody, programmed death-ligand 1 · Dako North America, Inc.
Key facts
| PMA number | P150027 |
|---|---|
| Trade name | PD-L1 IHC 28-8 pharmDx |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Dako North America, Inc. |
| Owner/operator | Agilent Technologies, Inc |
| Product code | PLS |
| Approval date | Jan 23, 2016 |
| Docket number | 16M-0803 |
| Notice date | Mar 3, 2016 |
| Establishment registration | 2022180 |
| FEI number | 2022180 |
At a glance
- 1–9 Supplements
- Mar 24, 2017 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: