PMA
P900013: ABBOTT PGR-EIA MONOCLONAL
FDA PMA · KIT, ASSAY, PROGESTERONE RECEPTOR · Abbott Laboratories
Key facts
| PMA number | P900013 |
|---|---|
| Trade name | ABBOTT PGR-EIA MONOCLONAL |
| Generic name | KIT, ASSAY, PROGESTERONE RECEPTOR |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LPI |
| Approval date | Sep 6, 1990 |
| Docket number | 90m-0299 |
| Notice date | Oct 23, 1990 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 1–9 Supplements
- Sep 22, 1999 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- Yes Withdrawn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: