PMA
P820052: RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
FDA PMA · KIT, ASSAY, PROGESTERONE RECEPTOR · Dupont Legal
Key facts
| PMA number | P820052 |
|---|---|
| Trade name | RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT |
| Generic name | KIT, ASSAY, PROGESTERONE RECEPTOR |
| Applicant | Dupont Legal |
| Product code | LPI |
| Approval date | Aug 31, 1983 |
| Notice date | Oct 12, 1983 |
At a glance
- 1–9 Supplements
- Aug 6, 1991 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- Yes Withdrawn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: