PMA
P900025: FLUORO-CEP (R) PROGESTERONE
FDA PMA · KIT, ASSAY, PROGESTERONE RECEPTOR · Zeus Scientific, Inc.
Key facts
| PMA number | P900025 |
|---|---|
| Trade name | FLUORO-CEP (R) PROGESTERONE |
| Generic name | KIT, ASSAY, PROGESTERONE RECEPTOR |
| Applicant | Zeus Scientific, Inc. |
| Owner/operator | ZEUS SCIENTIFIC LLC |
| Product code | LPI |
| Approval date | Sep 26, 1990 |
| Docket number | 90M-0442 |
| Notice date | Nov 23, 1990 |
| Establishment registration | 2242436 |
| FEI number | 2242436 |
At a glance
- 1–9 Supplements
- Apr 21, 1992 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- Yes Withdrawn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: