PMA supplement
P890065 S001: 1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
FDA PMA supplement · Normal 180 Day Track · DiaSorin, Inc.
Key facts
| Original PMA | P890065 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | 1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS |
| Generic name | RADIOIMMUNOASSAY FOR CYCLOSPORINE |
| Applicant | DiaSorin, Inc. |
| Product code | MGV |
| Received date | Oct 10, 1990 |
| Decision date | Jan 30, 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: