PMA
P800061: RIANEN 3H
FDA PMA · KIT, ASSAY, ESTROGEN RECEPTOR · Dupont Legal
Key facts
| PMA number | P800061 |
|---|---|
| Trade name | RIANEN 3H |
| Generic name | KIT, ASSAY, ESTROGEN RECEPTOR |
| Applicant | Dupont Legal |
| Product code | LPJ |
| Approval date | Jun 1, 1981 |
| Notice date | Jul 14, 1981 |
At a glance
- 10–99 Supplements
- Jan 16, 1986 Latest supplement decision
- Yes Withdrawn
- No 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: