PMA
P140025: VENTANA ALK (D5F3) CDX ASSAY
FDA PMA · Immunohistochemistry assay, antibody, anaplastic lymphoma kinase · Ventana Medical Systems, Inc.
Key facts
| PMA number | P140025 |
|---|---|
| Trade name | VENTANA ALK (D5F3) CDX ASSAY |
| Generic name | Immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | PKW |
| Approval date | Jun 12, 2015 |
| Docket number | 15M-2219 |
| Notice date | Jul 10, 2015 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 10–99 Supplements
- Jun 20, 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- No Withdrawn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: