PMA
P240026: OncoMate® MSI Dx Analysis System
FDA PMA · Nucleic Acid Based Assay, Microsatellite Instability · Promega Corporation
Key facts
| PMA number | P240026 |
|---|---|
| Trade name | OncoMate® MSI Dx Analysis System |
| Generic name | Nucleic Acid Based Assay, Microsatellite Instability |
| Applicant | Promega Corporation |
| Owner/operator | Promega Corporation |
| Product code | SFL |
| Approval date | Nov 5, 2025 |
| Docket number | FDA-6100 |
| Notice date | Nov 24, 2025 |
| Establishment registration | 2134567 |
| FEI number | 3002622561 |
At a glance
- None Supplements
- Nov 5, 2025 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- No Withdrawn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: