PMA supplement
P820052 S008: RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
FDA PMA supplement · Normal 180 Day Track · Dupont Legal
Key facts
| Original PMA | P820052 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT |
| Generic name | KIT, ASSAY, PROGESTERONE RECEPTOR |
| Applicant | Dupont Legal |
| Product code | LPI |
| Received date | Feb 15, 1991 |
| Decision date | Aug 6, 1991 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: