PMA
P890025: TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
FDA PMA · Fluorescence polarization immunoassay for cyclosporine · Abbott Laboratories
Key facts
| PMA number | P890025 |
|---|---|
| Trade name | TD CYCLOSPORINE AND METABOLITES SERUM ASSAY |
| Generic name | Fluorescence polarization immunoassay for cyclosporine |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MGU |
| Approval date | Dec 14, 1989 |
| Docket number | 89M-0523 |
| Notice date | Jan 19, 1990 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Sep 5, 2002 Latest supplement decision
- No Withdrawn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: