PMA
P890065: CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
FDA PMA · RADIOIMMUNOASSAY FOR CYCLOSPORINE · DiaSorin, Inc.
Key facts
| PMA number | P890065 |
|---|---|
| Trade name | CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS |
| Generic name | RADIOIMMUNOASSAY FOR CYCLOSPORINE |
| Applicant | DiaSorin, Inc. |
| Owner/operator | DiaSorin Inc. |
| Product code | MGV |
| Approval date | Sep 28, 1990 |
| Docket number | 90M-0444 |
| Notice date | Nov 2, 1990 |
| Establishment registration | 2182595 |
| FEI number | 2182595 |
At a glance
- 1–9 Supplements
- Jan 30, 1991 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- No Withdrawn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: