PMA
P220005: CRCDx RAS Mutation Detection Assay Kit
FDA PMA · Somatic gene mutation detection system · Entrogen, Inc.
Key facts
| PMA number | P220005 |
|---|---|
| Trade name | CRCDx RAS Mutation Detection Assay Kit |
| Generic name | Somatic gene mutation detection system |
| Applicant | Entrogen, Inc. |
| Owner/operator | EntroGen, Inc |
| Product code | OWD |
| Approval date | Sep 29, 2023 |
| Establishment registration | 3010791816 |
| FEI number | 3010791816 |
At a glance
- None Supplements
- Sep 29, 2023 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- No Withdrawn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: